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Description: Department: Industrial Machining Reports to: Production Supervisor Position Type: Hourly, RFT About the Company: DwyerOmega is a globally trusted leader in manufacturing innovative instrumentation solutions for the Process Measurement, Automation, Control and HVAC markets. With very strong brand recognition and high levels of customer loyalty, DwyerOmega has an unmatched reputation for providing customized solutions that meet and exceed customer needs. Our team of engineering experts help our customers select technical, and often configured, product solutions for their unique applications. The company offers over 300,000 state-of-the-art products for process measurement and control of temperature, humidity, pressure, strain, force, flow, level, pH, conductivity, and indoor air quality, and is a recognized global leader in the digital marketing of technical products. The products that we manufacture are used to control and drive process efficiency, creating safe and sustainable environments. At DwyerOmega, we enable our customers to improve the world – one measurement at a time. We achieve this through our unwavering commitment to technology, customer service, and overall continuous improvement. Every day, we strive to cultivate a culture of ingenuity, empowerment, accountability, adaptability, and speed. The company’s corporate headquarters are based in Michigan City, Indiana, and Norwalk, CT with manufacturing locations and sales offices located throughout the world. Position Summary: The Assembler is responsible for performing electro-mechanical assembly operations of light to moderate complexity in support of production goals. This role requires attention to detail, manual dexterity, and adherence to safety and quality standards to ensure products meet design and performance requirements. Alternative Work Schedule (AWS): Monday through Thursday, four 10-hour workdays per week. Shifts may start as early as 5:00 a.m. based on business needs. Essential Job Functions Prepare, clean, and organize parts and components prior to assembly. Perform electro-mechanical assembly work of light to moderate complexity, requiring fitting, alignment, and adjustment of components, using job orders, drawings, and other documentation. Conduct basic functional testing of completed assemblies, including dielectric and insulation resistance testing. Rework and repair non-conforming production assemblies in accordance with established procedures. Follow all safe work practices and company safety policies. Participate in required safety training programs. Promptly report unsafe conditions, near misses, or accidents to supervision. Safety Responsibilities Understand and support the company’s quality policy and applicable elements of the quality management system. Take responsibility for reducing, eliminating, and preventing quality deficiencies, including product escapes. Initiate action to prevent nonconformities related to products, process, or quality systems. Identify quality issues and elevate concerns through appropriate channels for corrective action. Exercise authority and responsibility to uphold quality standards in daily work. Quality Responsibilities Understand and support the Quality Policy and applicable elements of the Quality Management System relevant to assigned work areas. Take proactive action to reduce, eliminate, and prevent quality deficiencies, including product or process escapes. Initiate actions to prevent nonconformities related to products, processes, and quality systems. Exercise responsibility and authority to identify quality concerns and elevate issues for timely resolution within the quality system. Communication Communicate effectively in English, both verbally and in writing. Maintain professional, constructive, and collaborative working relationships with internal teams and external stakeholders. Essential/Preferred Skills: 0–2 years of experience in electro-mechanical assembly or repair of electro-mechanical devices, instruments, or units preferred. High School diploma or GED preferred. Demonstrated manual dexterity and mechanical aptitude, including proficient use of hand tools. Ability to perform repetitive assembly, testing, and potting operations with consistency and accuracy. Ability to read and follow general procedures, assembly drawings, and wiring diagrams. Ability to follow detailed instructions and established procedures with minimal supervision. Ability to perform repetitive tasks in a production or manufacturing environment while maintaining quality and efficiency. Requirements: Requirements Work Conditions and Physical Requirements: Work is performed in a manufacturing and production environment with regular exposure to moving mechanical parts, hand tools, and test equipment. May involve exposure to electrical components, adhesives, solvents, and potting materials, with appropriate safety controls and required use of personal protective equipment (PPE). Noise levels are generally moderate and may vary based on production activity. Work may be performed while standing or sitting at an assembly workstation for extended periods. Requires repetitive use of hands and wrists for assembly, testing, inspection, and material handling tasks. Requires fine motor skills, manual dexterity, and the ability to use hand tools and test instruments with precision. Requires the ability to bend, reach, walk, and move within the work area as needed throughout the shift. Must be able to lift, carry, push, and pull materials weighing up to 25 pounds, with or without reasonable accommodation. Requires the ability to visually inspect small components, read drawings, labels, and computer screens, with or without corrective lenses. At DwyerOmega, we’re committed to fair, transparent compensation. All U.S. job postings include a good-faith salary range that reflects the role, location, experience, and internal equity. We encourage open conversations about pay and are happy to discuss compensation at any stage of the hiring process.
Description: Department: Industrial Machining Reports to: Production Supervisor Position Type: Hourly, RFT About the Company: DwyerOmega is a globally trusted leader in manufacturing innovative instrumentation solutions for the Process Measurement, Automation, Control and HVAC markets. With very strong brand recognition and high levels of customer loyalty, DwyerOmega has an unmatched reputation for providing customized solutions that meet and exceed customer needs. Our team of engineering experts help our customers select technical, and often configured, product solutions for their unique applications. The company offers over 300,000 state-of-the-art products for process measurement and control of temperature, humidity, pressure, strain, force, flow, level, pH, conductivity, and indoor air quality, and is a recognized global leader in the digital marketing of technical products. The products that we manufacture are used to control and drive process efficiency, creating safe and sustainable environments. At DwyerOmega, we enable our customers to improve the world – one measurement at a time. We achieve this through our unwavering commitment to technology, customer service, and overall continuous improvement. Every day, we strive to cultivate a culture of ingenuity, empowerment, accountability, adaptability, and speed. The company’s corporate headquarters are based in Michigan City, Indiana, and Norwalk, CT with manufacturing locations and sales offices located throughout the world. Position Summary: The Assembler is responsible for performing electro-mechanical assembly operations of light to moderate complexity in support of production goals. This role requires attention to detail, manual dexterity, and adherence to safety and quality standards to ensure products meet design and performance requirements. Essential Job Functions: Prepare, clean, and organize parts and components prior to assembly. Perform electro-mechanical assembly work of light to moderate complexity, requiring fitting, alignment, and adjustment of components, using job orders, drawings, and other documentation. Conduct basic functional testing of completed assemblies, including dielectric and insulation resistance testing. Rework and repair non-conforming production assemblies in accordance with established procedures. Follow all safe work practices and company safety policies. Participate in required safety training programs. Promptly report unsafe conditions, near misses, or accidents to supervision. Safety Responsibilities: Understand and support the company’s quality policy and applicable elements of the quality management system. Take responsibility for reducing, eliminating, and preventing quality deficiencies, including product escapes. Initiate action to prevent nonconformities related to products, process, or quality systems. Identify quality issues and elevate concerns through appropriate channels for corrective action. Exercise authority and responsibility to uphold quality standards in daily work. Quality Responsibilities: Understand and support the Quality Policy and applicable elements of the Quality Management System relevant to assigned work areas. Take proactive action to reduce, eliminate, and prevent quality deficiencies, including product or process escapes. Initiate actions to prevent nonconformities related to products, processes, and quality systems. Exercise responsibility and authority to identify quality concerns and elevate issues for timely resolution within the quality system. Communication: Communicate effectively in English, both verbally and in writing. Maintain professional, constructive, and collaborative working relationships with internal teams and external stakeholders. Essential/Preferred Skills: 0–2 years of experience in electro-mechanical assembly or repair of electro-mechanical devices, instruments, or units preferred. High School diploma or GED preferred. Demonstrated manual dexterity and mechanical aptitude, including proficient use of hand tools. Ability to perform repetitive assembly, testing, and potting operations with consistency and accuracy. Ability to read and follow general procedures, assembly drawings, and wiring diagrams. Ability to follow detailed instructions and established procedures with minimal supervision. Ability to perform repetitive tasks in a production or manufacturing environment while maintaining quality and efficiency. Requirements: Work Conditions and Physical Requirements: Work is performed in a manufacturing and production environment with regular exposure to moving mechanical parts, hand tools, and test equipment. May involve exposure to electrical components, adhesives, solvents, and potting materials, with appropriate safety controls and required use of personal protective equipment (PPE). Noise levels are generally moderate and may vary based on production activity. Work may be performed while standing or sitting at an assembly workstation for extended periods. Requires repetitive use of hands and wrists for assembly, testing, inspection, and material handling tasks. Requires fine motor skills, manual dexterity, and the ability to use hand tools and test instruments with precision. Requires the ability to bend, reach, walk, and move within the work area as needed throughout the shift. Must be able to lift, carry, push, and pull materials weighing up to 25 pounds, with or without reasonable accommodation. Requires the ability to visually inspect small components, read drawings, labels, and computer screens, with or without corrective lenses. At DwyerOmega, we’re committed to fair, transparent compensation. All U.S. job postings include a good-faith salary range that reflects the role, location, experience, and internal equity. We encourage open conversations about pay and are happy to discuss compensation at any stage of the hiring process.
Job Description We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission! We are seeking a highly effective Senior Validation Engineer responsible for planning, execution, and documentation of commissioning, qualification, and validation activities for manufacturing and Quality Control equipment, facilities, utilities, and related systems. The role requires extensive hands-on validation experience, including protocol authoring, field execution, data analysis, technical report generation, and support of digital validation processes through KNEAT and other validation systems. Responsibilities (include but are not limited to): Responsible for performing validation of manufacturing and Quality Control equipment, storage areas, utility systems, facilities, processes, and/or automation systems. This includes developing validation master plans with minimal supervision, preparing protocols independently, analyzing test results, and preparing technical reports. Develop, execute, and analyze temperature mapping and autoclave heat penetration studies to support equipment qualification and regulatory compliance. Lead validation projects through the development of validation schedules, master plans, protocols, reports, and related lifecycle documentation for systems supporting clinical and commercial manufacturing. Perform, lead, and document commissioning, qualification, validation, and temperature mapping activities for facilities, utilities, equipment, storage environments, and related systems in accordance with SOPs, cGMPs, and regulatory requirements. Serve as the KNEAT SME and power user, providing technical guidance, user support, process improvements, and expertise in the execution and management of digital validation records and workflows. Coordinates validation activities with, and seeks team supports from, Validation, Development, Manufacturing, Engineering, Quality, third Parties, and other groups on validation projects to ensure validation projects are carried out on time and on budget. Coordinates the activities of assigned validation contract personnel and ensures the quality of completed work. Investigate validation deviations or failures, identify root causes, support corrective actions, and escalate technical or compliance risks as appropriate. Maintain compliant validation records and support data integrity, documentation quality, and lifecycle validation requirements. Provide technical guidance to validation technicians, junior staff, internal teams, contractors, and vendors. Represents the department on cross-functional project teams. As required, assists in preparation of regulatory submissions and presents validations in respective SME areas to regulatory authorities during routine internal and pre-approval inspections. Support occasional night, weekend, or off-shift work based on business needs. Additional duties as assigned. Basic Qualifications: Bachelor’s degree in engineering, engineering technology, or related field with 7+ years of experience in equipment, facility, and utilities validation. Master’s degree with 5+ years of experience in validation in a biotech/pharma industry Experience in GMP/cGMP-regulated environments Extensive hands-on experience developing, executing, and documenting commissioning, qualification, and validation activities, including protocol authoring, field execution, data analysis, deviation resolution, and report generation. Preferred Qualifications: Experience validating equipment, facilities, and utility systems within a GMP-regulated biotechnology or pharmaceutical manufacturing environment. In-depth understanding and application of validation principles, concepts, practices, and standards. Working knowledge of cell therapy manufacturing equipment, utility systems, and supporting infrastructure. Experience with digital validation systems, including KNEAT, electronic validation workflows, and data management practices. Experience developing and executing temperature mapping studies and autoclave heat penetration studies. In-depth knowledge of current Good Manufacturing Practices (GMPs). Experience supporting regulatory inspections and interactions with health authorities. Excellent verbal, written, and interpersonal communication skills Demonstrated investigation and report writing skills. Proficient in Microsoft Office applications. Strong analytical, problem-solving, and critical-thinking skills. The salary range for this position is: $123,930.00 - $160,380.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
What if the work you did every day could impact the lives of people you know? Or all of humanity? At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients. Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible. The Equipment Maintenance Technician is part of the equipment engineer team who provides expertise, service, and support to San Diego Illumina headquarters by maintaining equipment at world-class levels in a fast pace regulated environment and providing high-level reliability exceeding Illumina’s dynamic development and manufacturing demands. The Equipment Maintenance Technician will support the day to day manufacturing equipment maintenance operations by owning high complexity maintenance task and challenges, with minimal supervision. This individual will work in a dynamic team-oriented environment that supports multiple operations and technologies helping Illumina deliver its highly complex product pipeline in a reliable and sustainable manner. Work Schedule: 2pm to 10:30pm M-F Responsibilities: Able to complete high complexity tasks with minimal supervision and report/track progress through a digital ticketing system. Capable of executing procedures without established instructions and capable of referencing written documentation. Escalate problems to engineers, suggest solutions, and work with engineers to address advanced issues. Independently plan, coordinate, and execute multiple parallel activities like calibrations, preventive maintenance, supplier support, and project activities with minimal guidance to ensure work is completed on-time. Make suggestions for continuous improvement and cost savings M onitors equipment technical performance and manage technical inventory for area of responsibility with minimal oversight. Use optical, mechanical, electrical, and or fluidics knowledge to perform equipment troubleshooting. Work in a team environment to improve equipment reliability and uptime. While performing the duties of this job, is regularly required to stand, sit, walk, climb stairs/ladders, kneel, crouch, or wear safety gear. Must regularly lift and / or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds. Requirements: Ability to operate in a fast pace environment, adapt to changes in priority, and redirect efforts as necessary. Ability to use Microsoft Office and Windows Advanced data collection, hands-on skills and able to summarize results Automated liquid handler repair and troubleshooting is preferred Chemical Analytical equipment repair and troubleshooting is preferred Excellent math and analytical skills Excellent verbal and written documentation skills in English Experience in high volume manufacturing environment preferred Experience using engineering troubleshooting tools Experience with electrical and mechanical schematics Experience with optical/mechanical/electrical and or fluidic systems Knowledge of GMP (Good Manufacturing Practice) would be a plus This position has an open schedule and or rotation scheduled between shifts and will include weekends Work experience in Life Sciences / Pharmaceutical / Medical Devices industries would be an advantage Travel up to 10% Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs. Experience/Education: High School Diploma or equivalent; associates degree preferred At least 4 years of related experience The estimated base hourly range for the Production Maintenance Technician 2 (2nd Shift) role based in the United States of America is: $25.28 - $37.88. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. The range reflects long‑term growth in the role; therefore, most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off. We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact [email protected]. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.
About INOVIO INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO’s technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com. Job summary The Quality Engineer III provides quality engineering leadership and technical support for INOVIO’s electromechanical medical devices and combination products throughout manufacturing, testing, release, and post-production quality activities. This position independently manages complex quality engineering assignments, including nonconformance investigations, material review and disposition, corrective and preventive actions, supplier quality, change control, quality-system documentation, inspection methods, and continuous improvement initiatives. The Quality Engineer III applies engineering principles, risk-based decision-making, statistical methods, and knowledge of applicable regulatory and quality-system requirements to evaluate product, process, and supplier quality issues. The position is responsible for developing technically sound and audit-defensible conclusions, recommending appropriate containment and corrective actions, and ensuring that quality records are complete, accurate, traceable, and supported by objective evidence. The Quality Engineer III collaborates with Engineering, Manufacturing, Quality Control, Supply Chain, Regulatory Affairs, and external suppliers to resolve quality issues and maintain product, process, and regulatory compliance. This role exercises independent technical judgment, leads cross-functional activities without direct authority, communicates quality and compliance risks to management, and performs assigned responsibilities with minimal supervision. Essential job functions and duties Lead or independently manage nonconformance investigations, including containment, potential root causes, risk assessment, product disposition, verification of actions, and closure. Lead or support Material Review Board activities and ensure that product and material dispositions are technically justified and properly documented. Lead or support CAPA and ISSUE activities, including investigation, root causes determination, action planning, implementation, and effectiveness verification. Identify recurring or systemic quality issues and recommend escalation through the appropriate quality-system process. Lead or support supplier-quality activities, including supplier investigations, SCARs, corrective-action review, supplier changes, qualification, monitoring, and audits. Review supplier failure analyses and coordinate appropriate containment, screening, inspection, return, replacement, or corrective actions. Review Device History Records, inspection records, test results, and supporting documentation to support product and component release decisions. Provide technical support for incoming, in-process, and finished-product inspection, including interpretation of drawings, specifications, tolerances, and acceptance criteria. Support development and improvement of inspection methods, sampling plans, measurement systems, quality plans, and manufacturing controls. Develop and revise quality-system procedures, work instructions, forms, and electronic workflows. Analyze and present quality metrics and trends related to nonconformances, supplier performance, recurring defects, and investigation status. Serve as a Quality Engineering subject matter expert during internal audits, supplier audits, regulatory inspections, and inspection-readiness activities. Lead cross-functional quality activities, communicate significant risks to management, and provide technical guidance and mentoring to less-experienced personnel. Perform other duties consistent with the responsibilities and level of the position. Minimum requirements Bachelor’s degree in engineering, science, or a related technical discipline, or an equivalent combination of education and directly relevant experience. Minimum 5+ years of progressive experience in quality engineering, manufacturing engineering, supplier quality, or a related technical function within the medical-device, biotechnology, pharmaceutical, combination-product, or another regulated industry. Demonstrated experience independently leading nonconformance investigations, material review and dispositions activities, CAPA activities, supplier quality issues, and cross-functional quality projects. Working knowledge of applicable FDA quality-system and current good manufacturing practice requirements, ISO 13485, and ISO 14971. Familiarity with 21 CFR Part 4 and combination product requirements is preferred. Experience applying root-cause analysis, risk assessment, statistical methods, inspection processes, and problem solving techniques to quality and manufacturing issues. Ability to analyze technical information and make sound, risk-based quality recommendations supported by objective evidence with limited supervision. Demonstrated ability to lead cross-functional activities and drive assigned actions to completion without direct authority. Proficiency with Microsoft Office applications and experience with electronic Quality Management Systems (eQMS), such as MasterControl or equivalent. Experience with electromechanical medical devices, electronic assemblies, contract manufacturers, statistical software, or automated inspection equipment is preferred. Disclaimer INOVIO Pharmaceuticals, Inc. is an Equal Employment Opportunity Employer, including but not limited to veterans and individuals with disabilities. We prohibit discrimination of any kind. In keeping with our policy, we recruit, hire, train, and promote the most qualified individuals for all job titles, and we provide equal opportunities to all employees and applicants for employment. A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. INOVIO offers an attractive benefits package and is an equal opportunity employer. Important notice to employment businesses/agencies INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO.
About INOVIO INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO’s technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com. Job summary The Temporary Manufacturing Electrical Engineer II provides technical support for investigation, analysis, and resolution of device issues identified during manufacturing and from the field. This role partners closely with Quality members to ensure issues are properly documented and addressed within INOVIO’s Quality Management System (QMS). The engineer supports existing medical device products and manufacturing operations, ensuring products are manufactured in compliance with established procedures, quality standards, and regulatory requirements. Essential job functions and duties Investigate product complaints, field returns, and manufacturing-related issues to determine root causes and implement corrective actions. Support Quality System Technical Compliance activities, including participation in Material Review Board, Non-Conforming Material Review (NCMR), and Corrective and Preventative Action (CAPA) processes. Troubleshoot and support PCB and PCBA manufacturing processes and related electrical assemblies. Evaluate, investigate, and troubleshoot electrical systems, products, components, and applications using knowledge of electronics, software, manufacturing processes, and materials. Resolve and document technical issues encountered during manufacturing and servicing while supporting continuous improvement (CI) initiatives in accordance with GMP requirements. Support manufacturing line processes, process validation, and product development efforts. Create and revise Manufacturing and testing work instructions, including visual aids, Specifications, Inspection procedures, and qualification documentation. Generate and/or review product development documentation, including plans, specifications, procedures (test, manufacturing, and quality control), reports, design review documentation, and validation records. Participate in design reviews. Provide engineering support for other departments and perform additional Manufacturing Engineering responsibilities as needed. Minimum requirements Bachelor's degree in Electrical Engineering (BSEE) or Industrial Engineering (BSIE) with a strong electronics background. Minimum of 3 years of electrical engineering experience in a regulated manufacturing environment; medical device or biotech industry experience preferred. Ability to read and understand electrical schematics, PCB layouts, and mechanical drawings. Experience troubleshooting analog circuits, including op-amps, amplifiers, passive components, A/D and D/A converters, and opto-electrical devices. Experience with digital circuits, integrated circuits (IC), PCB design, and circuit analysis. Familiarity with servo motor controls and feedback systems. Proficiency using laboratory test equipment, including oscilloscopes, function generators, power supplies, and digital multi-meters. Experience conducting failure analysis, troubleshooting, circuit debugging, and bench top testing. Experience supporting manufacturing operations, production line troubleshooting, and product servicing activities. Working knowledge of tolerance analysis and related engineering methodologies. Proficiency with Microsoft Office applications. Experience with electronic design tools such as OrCAD CIS, LTSpice, Allegro, and PADS preferred. Experience with manufacturing automation systems, including Human Machine Interfaces, Programmable Logic Controllers, Latter Logic preferred. Knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, CE, and UL Requirements preferred. Experience creating and maintaining engineering documentation, manufacturing, procedures, test methods, validation protocols, and technical reports.
About INOVIO INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO’s technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com. Job summary The Temporary Quality Engineer II provides hands-on quality engineering, and quality systems support for product development and pilot manufacturing activities. This position supports a variety of assigned quality projects, including document creation and updates, record review, and follow-up on action items. This role will assist with implementation and maintenance of quality processes related to process changes, documentation updates, quality metrics, management review support, and general quality system compliance activities. The temporary Quality Engineer II will work cross-functionally with Engineering, Manufacturing, Quality Control, and other functions to help ensure that quality records are complete, accurate, timely, and compliant. This role requires strong attention to detail, solid organizational skills, technical capability, and the ability to work effectively in a fast-paced environment with shifting priorities. This position requires flexibility and willingness to support both technical and routine quality tasks as needed. Experience in regulated environments and the ability to analyze information, communicate clearly, and work effectively with engineers and operations teams is important. This role supports activities within a quality system aligned with applicable medical devices and combination product quality requirements, including FDA QMSR, ISO 13485:2016, ISO 14971:2019, and applicable constituent-part quality requirements under 21 CFR Part 4. Essential job functions and duties Support day-to-day activities related to quality engineering and quality systems operations. Support preparation, review, and revision of quality system documents (SOPs, work instructions, forms, and quality records) to ensure accuracy, clarity, and compliance. Review completed records for completeness, accuracy, data integrity, and adherence to applicable procedures and regulatory expectations. Support collection, compilation, and trending of quality metrics and other data for management reporting, process monitoring, and quality improvement activities. Support manufacturing related activities such as calibration and preventive maintenance programs for manufacturing, laboratory, inspection, and quality equipment. Support equipment qualification and validation activities, including IQ/OQ/PQ documentation as assigned. Help identify documentation gaps, incomplete or overdue records, and other quality system issues requiring escalation or corrective action. Work closely with engineers and other cross-functional team members to obtain technical information required to complete quality records, investigations, and documentation accurately. Support investigations, CAPAs, and process improvement activities as assigned. Maintain organized files and records within paper-based and/or electronic quality systems. Perform other duties as required to support Quality Assurance and quality systems operations in fast-paced environment. Minimum requirements Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical discipline. Minimum 2–5 years of quality engineering or quality systems experience in a regulated medical device, combination product, biotechnology, or similarly regulated environment. Working knowledge of quality system requirements applicable to medical devices and/or combination products, including FDA QMSR / 21 CFR Part 820, ISO 13485:2016, ISO 14971:2019 and applicable elements of 21 CFR Part 4. Experience authoring or revising SOPs, work instructions, forms, templates, validation-related documents, or other controlled quality system documentation. Experience with change control, document control, nonconformance, CAPA, or other core quality system processes. Experience with equipment qualification and computerized systems. Experience working cross-functionally with engineering teams and reviewing technical documentation such as drawings, specifications, design documents, test methods, validation documents, and risk management records. Ability to manage multiple assignments and deliver high-quality work within timelines in a dynamic environment. Proficiency in Microsoft Office applications, especially Excel, Word, PowerPoint, and Outlook. Preferred experience with electromechanical devices, software-controlled devices, manufacturing process changes, design changes, or validation change impacts. Preferred experience with eQMS platforms such as MasterControl or similar systems. Preferred Experience using electronic calibration, maintenance, and asset management systems, preferably Blue Mountain Regulatory Asset Manager (BMRAM). Preferred experience using statistical analysis software such as Minitab, JMP, or comparable tools Preferred experience supporting combination products, including constituent-part quality system considerations. Preferred ability to work independently with limited supervision while exercising sound judgment in identifying and escalating compliance or quality risks. Six Sigma Green Belt, Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or other relevant quality certification preferred. Disclaimer INOVIO Pharmaceuticals, Inc. is an Equal Employment Opportunity Employer, including but not limited to veterans and individuals with disabilities. We prohibit discrimination of any kind. In keeping with our policy, we recruit, hire, train, and promote the most qualified individuals for all job titles, and we provide equal opportunities to all employees and applicants for employment. A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. INOVIO offers an attractive benefits package and is an equal opportunity employer. Important notice to employment businesses/agencies INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO.
R&R Industries Inc. in San Clemente, CA is looking to hire *full-time Production Worker *to join our Silk Screen Decorating Department. This role is essential to ensure the smooth operation of our Silk Screen printing process by catching and organizing printed items, inspecting for quality, stacking and sorting finished products, and maintaining a clean and efficient work area. _*¡Hablamos Español!*_ *Pay is starting from $19/hr. depending on experience.* *Hours are Monday through Friday, from 6am - 2:30pm;*_*Overtime required during peak seasons.*_ *Production Responsibilities Include:* * Support receiving garments from the production dryer belt * Conduct quality inspection of the quantity and quality of printed goods * Responsible for handling and repetitively counting hundreds of items daily * Ensure each order is physically accurate and matches our ERP System, meeting and/or exceeding customer satisfaction * Package and label orders in a timely manner * Ability to multi-task while paying attention to quality of printed products * Ability to meet daily orders and print targets * Work alongside a garment dryer where the surrounding temperature is warm * Keep the general maintenance of work area clean and organized * Perform other responsibilities as needed *Production Required Skills and Experience:* * Experience in a production line or similar environment preferred, but not required. * Must be able to regularly lift up to 40lbs. * Must be able to stand for extended periods of time * Frequent repetitive hand motion * Must be able to keep up in fast paced production environment & consistent workflow*.* Thank you for your interest in R&R Industries! *If this sounds like a fit, apply or call today!* We want hungry people to join our team and help take us to the next level. R&R Industries, Inc. is an apparel manufacturer specializing in high-visibility clothing. Many of our customers are in the construction, airlines, and landscaping industries. We decorate their logos on-site. *Note: No agencies.* All candidates/resumes submitted by an agency or 3rd party will be considered a referral. *We are an E-Verify Employer.* _We are an equal opportunity employer and value diversity at R & R Industries, Inc. _ _We do not discriminate on the basis of race, religion, color, national origin, gender or gender identity, sexual orientation, age, marital status, veteran or disability status, or any other characteristic protected by law._ Job Type: Full-time Pay: From $19.00 per hour Benefits: * 401(k) * Dental insurance * Health insurance * Paid time off * Referral program * Vision insurance Ability to Commute: * San Clemente, CA 92672 (Required) Ability to Relocate: * San Clemente, CA 92672: Relocate before starting work (Required) Work Location: In person
GROW WITH US AND STAY EXTRAORDINARY: Launch your career to new heights with Innoflight—one of San Diego’s fastest-growing Aerospace and Defense innovators. Here, visionary minds engineer the future of space technology through pioneering, compact, and cyber-secure solutions. From software-defined radios to cutting-edge cryptographic systems and avionics, everything we build powers the next era of New Space. Join our small, agile, and mission-driven team where your work has real impact and your growth has no limits. We’re not just reaching for the stars—we’re engineering them. Let’s innovate the infinite, together. A DAY IN THE LIFE: As a Quality Specialist II, you will play an important role in ensuring Innoflight's aerospace products meet rigorous quality, reliability, and compliance standards. You'll work across Quality, Engineering, Manufacturing, and Operations to review product documentation, perform inspections, investigate quality issues, and support corrective actions. With increasing independence and technical responsibility, you'll help improve quality processes, support customer and supplier needs, and contribute to continuous improvement initiatives across the organization. WHAT YOU'LL DO: Reviews Product Documentation: Reviews End Item Data Packages (EIDPs) for product assembly, testing, and process verification, ensuring documentation is complete, accurate, and aligned with established requirements. Performs Quality Inspections: Conducts and documents routine inspections and quality tests to verify products and processes meet specifications and established quality standards. Drives Quality Improvements: Implements, monitors, and improves quality assurance policies and procedures while identifying opportunities to streamline processes and improve efficiency. Optimizes EIDP Processes: Develops value-added improvements to the EIDP review process, increasing review accuracy, consistency, and overall efficiency. Supports Quality Compliance: Helps sustain AS9003 compliance and contributes to initiatives supporting AS9100 certification and ongoing quality system improvements. Identifies Process Issues: Investigates production workflow and process issues, identifies potential causes, and develops actionable recommendations to improve product and process quality. Analyzes Quality Data: Creates and maintains quality metrics and reports to monitor performance, identify trends, and support data-driven decision-making. Supports Configuration Management: Collaborates with Configuration Management to manage change orders, deviations, and other changes that may affect established production and quality processes. Participates in MRB Activities: Supports Material Review Board (MRB) activities by evaluating quality anomalies, documenting findings, and recommending appropriate corrective actions. Supports Customers & Suppliers: Provides quality support for hardware and software issues, communicates effectively with customers and suppliers, and participates in supplier oversight activities and limited travel as needed. Manages RMA Activities: Assists with Return Material Authorization (RMA) workflows to support efficient product returns, repairs, and issue resolution. Collaborates Across Teams: Partners with Quality, Engineering, Manufacturing, Operations, and other cross-functional teams to support department objectives and resolve quality-related challenges. YOU’RE AWESOME AT: Quality Assurance: Applying quality principles, inspection practices, and established procedures to identify issues and ensure products consistently meet requirements. Documentation & Data Analysis: Reviewing detailed technical documentation, maintaining accurate records, and using quality metrics to identify trends and opportunities for improvement. Problem Solving: Investigating production and process issues, evaluating quality anomalies, and developing practical recommendations for corrective action. Cross-Functional Collaboration: Communicating effectively across Quality, Engineering, Manufacturing, Operations, customers, and suppliers to facilitate discussions and drive timely resolutions. WHAT YOU’LL NEED: Associate's Degree or higher in Engineering, Electrical Engineering, Aerospace Engineering, or a related field preferred. 3 or more years of cross-functional experience in Manufacturing, Quality Assurance, Engineering, and Operations. Experience in electronics, avionics, aerospace, or a related high-reliability industry preferred. Proficiency with business systems and databases for data entry, reporting, and data extraction. Strong computer skills, including Microsoft Office applications such as Outlook, Word, Excel, PowerPoint, and Visio. Ability to work independently, manage multiple priorities, and adapt to a fast-paced, growth-oriented environment. Strong written and verbal communication skills with the ability to collaborate effectively across teams. Exceptional attention to detail, accuracy, and commitment to delivering high-quality results. Ability to obtain a U.S. Security Clearance. COMPENSATION & BENEFITS: The starting hourly rate for this position ranges from $35.00 to $50.00 per hour, depending on the candidate’s job-related knowledge, skills, and experience. In addition to a competitive base salary, Innoflight offers a well-rounded compensation package that includes a Profit-Sharing Bonus and a Cash Performance Bonus to reward both individual and company performance. Additional benefits include: 401(k) with 3% company match (automatic enrollment) Comprehensive medical, dental, vision, HSA & life insurance 10 paid holidays + 120 hours PTO (starting in year one) Access to ancillary benefits such as critical illness, accident, disability, legal and pet insurance. WHY YOU’LL LOVE WORKING HERE: Flexible Work-Life Balance: Enjoy a 9/80 work schedule with every other Friday off—whether you use it to recharge, work on a passion project, or spend time with family, the choice is yours. Continuous Learning & Development: We’re serious about professional development. From tuition reimbursement to internal "Ask Me Anything" sessions and weekly “Lunch & Learns,” we make learning a core part of the job. Mission-Driven Culture: We aren’t just building tech—we’re enabling the next era of space exploration. Our Culture Ambassadors help lead initiatives around inclusion, positivity, recognition, and transparency. Here, your voice is heard, your work is respected, and your individuality is celebrated. BE YOU, WITH US: At Innoflight, we are committed to fostering an inclusive and equitable workplace where everyone belongs. We recognize that great talent comes in many forms, and you don’t need to meet every requirement to bring value to our team. If this role excites you, we encourage you to apply—even if you don’t check every box. YOU SHOULD KNOW: Potential new employees must successfully complete a background check which includes criminal search, education certification and employment verification prior to hire. Applicants must be authorized to work for any employer in the U.S as you must have the ability to obtain a security clearance. We are unable to sponsor or take over sponsorship of an employment Visa. A NOTE TO STAFFING AGENCIES: Innoflight does not accept unsolicited resumes from agencies, recruiters, or any third-party sources. Any such submissions will be considered property of Innoflight, and no fees will be paid in the event a candidate is hired from an unsolicited referral. To California residents applying for this job, please read Innoflight’s CCPA Notice: https://www.innoflight.com/careers/california-consumer-privacy-act-notice-for-job-applicants. #LI-Onsite sfqC7EgF6P
Quality Control Technical Shift Lead Location: San Diego, CA | Employment Type: Full-Time Lead Daily QC Operations and Support Product Release At PolyPeptide, we partner with pharmaceutical and biotech companies to support the development and manufacturing of peptide-based therapies. We are looking for a Quality Control Technical Shift Lead to help oversee daily laboratory testing operations, support QC analysts, and ensure testing is completed accurately, efficiently, and in compliance with GMP requirements. This role is a strong fit for someone with hands-on QC laboratory experience who is ready to take the next step in leadership, or someone who has already served as a senior analyst, lead, or technical resource within a GMP-regulated laboratory. About the Role The Quality Control Technical Shift Lead is responsible for coordinating daily QC testing activities, prioritizing workload, monitoring sample turnaround times, and helping ensure critical testing is completed to support manufacturing and product release timelines. In this role, you will serve as a primary technical resource for QC analysts, support troubleshooting and laboratory investigations, review testing data, and collaborate closely with Quality Assurance, Manufacturing, and other cross-functional teams. You will play an important role in maintaining laboratory compliance, supporting continuous improvement, and promoting a strong culture of quality, accountability, and data integrity. What You Will Do Coordinate daily QC testing activities, scheduling, planning, and project priorities. Assign workload to analysts based on staffing levels, testing needs, and business priorities. Monitor sample turnaround times and testing schedules to support timely material and product release. Provide input on capacity constraints that may impact schedule adherence. Support compliance with USP, EP, ICH, cGMP, SOPs, regulatory submissions, and data integrity standards. Serve as a technical resource for QC analysts and provide guidance on testing, troubleshooting, and laboratory practices. Execute complex testing and operate analytical instruments to support raw material, intermediate, in-process, and finished product testing. Prepare samples and solutions in accordance with established methods and protocols. Calibrate testing and measurement equipment to ensure accuracy and reliability. Review test result data and identify issues related to materials, products, methods, or equipment. Recommend solutions or corrective actions for quality issues. Support general “Go / No Go” processing decisions as appropriate. Maintain high laboratory organization and cleanliness standards, including 5S and Kanban practices. Approve time reporting documents and support daily team coordination. Perform additional duties as required. What We Are Looking For Education and Experience Bachelor’s degree in chemistry, biochemistry, or a related life sciences field required. 4+ years of experience in a GMP-regulated Quality Control laboratory. At least 1 year of experience in a leadership, senior analyst, technical lead, or team lead capacity. Experience supporting laboratory workload planning, troubleshooting, investigations, or analyst guidance preferred. Experience with peptide products is highly desirable. Technical Skills Hands-on experience with HPLC, GC, and other analytical instrumentation. Strong understanding of cGMP, ICH, USP, EP, and applicable regulatory guidelines. Experience reviewing analytical data and supporting documentation accuracy. Ability to troubleshoot testing methods, instruments, and quality issues. Strong understanding of quality control principles, data integrity, and laboratory compliance expectations. Skills and Competencies Technical proficiency in analytical testing. Strong cGMP compliance and documentation accuracy. Problem-solving and quality issue resolution. Attention to detail and commitment to data integrity. Strong collaboration, communication, and interpersonal skills. Ability to lead daily priorities, support analysts, and foster accountability within the team. Solution-oriented mindset with a focus on quality, efficiency, and operational excellence. Why Join PolyPeptide? This is an opportunity to take on a visible technical leadership role within a GMP Quality Control laboratory. You will help guide daily testing activities, support analyst development, and contribute directly to manufacturing and product release timelines. As a QC Technical Shift Lead, your work will help ensure that materials and products are tested accurately, released on time, and held to high quality standards. This role is ideal for someone who enjoys balancing technical laboratory work with team coordination, troubleshooting, and cross-functional collaboration. Join PolyPeptide and help support high-quality testing, timely product release, and operational excellence within our Quality Control team. Salary: $33/hr - $40/hr We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
At Fluor, we are proud to design and build projects and careers. We are committed to fostering a welcoming and collaborative work environment that encourages big-picture thinking, brings out the best in our employees, and helps us develop innovative solutions that contribute to building a better world together. If this sounds like a culture you would like to work in, you’re invited to apply for this role. Job Description Under general supervision, this position operates complex building controls systems and executes commissioning, startup, and operational plans. This requires following best working practices and operating procedures to ensure safe and efficient operations of equipment. • Comply with all key work processes required by the company and documents any deficiencies • Perform and train others to perform plant operations in a safe, incident free, reliable manner while identifying opportunities to reduce costs, increase productivity, and most importantly, continually reduce the risk of accidents and injuries • Participate in job specific training, presentations, modules, qualification tests require to perform work and qualify for job rotations • Identify, document, and monitor key operating parameters; ensure data and forms are filed, retained, and distributed as required by plant practices • Ensure handovers among operators are thorough and clearly communicated and documented • Identify and track efficiency data associated with key operational activities; submit improvement ideas and support their adoption and implementation • Provide timely assistance to other plant operators when required • Maintain a clean and organized operating area • Maintain compliance with all applicable policies, procedures, and global standards • Plan, organize, and carry out assignments as directed • Adhere to and support Fluor’s Health, Safety & Environmental and Sustainability Policies • Effectively develop and apply the Core Skills to the job • Meet expectations on attendance and punctuality • Other duties as assigned Basic Job Requirements A combination of education and directly related experience equal to five (5) years*; some locations may have additional or different qualifications in order to comply with local regulations • Ability to communicate effectively with audiences that include but are not limited to management, coworkers, clients, vendors, contractors, and visitors • Job related technical knowledge necessary to complete the job • Ability to attend to detail and work in a time-conscious and time-effective manner Other Job Requirements Preferred Qualifications • Must have a technical diploma or technical college certificate or global equivalent • Minimum of five (5) years of experience in positions supporting plant operations or maintenance; having plant operating experience in a manufacturing environment is essential while having operational board experience is preferred • Must have knowledge and experience of plant operations including aspects of planning, training, scheduling, safe work practices and incident free operations • Must have excellent verbal and written English communications skills • Work effectively with multi-cultural personnel to execute work assignments • Strong interpersonal and mentoring skills and organizational accountability processes • Good multi-tasking skills • Proficient in MS-Office programs We are an equal opportunity employer. All qualified individuals will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, genetic information, or any other criteria protected by governing law. Benefits Statement: Fluor is proud to offer a comprehensive benefits package designed to promote employee health, wellness, and financial security. Our offerings include medical, dental and vision plans, EAP, disability coverage, life insurance, AD&D, voluntary benefit plans, 401(k) with a company match, paid time off (personal, bereavement, sick, holidays) for salaried employees, paid sick leave per state requirement for craft employees, parental leave, and training and development courses. Market Rate Statement: The market rate for the role is typically at the mid-point of the salary range; however, variations in final salary are determined by additional factors such as the candidate’s qualifications, relevant years of experience, geographic location, internal pay equity, and prevailing market conditions for the specific role. Notice to Candidates: Background checks are carried out as part of any conditional offer made, including (but not limited to & role dependent) education, professional registration, employment, references, passport verifications and Global Watchlist screening. To be Considered Candidates: Must be authorized to work in the country where the position is located. Salary Range: $57,500.00 - $107,500.00
GROW WITH US: Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry. STAY AWESOME: Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology — an advanced predictive algorithm that automates insulin delivery. But we’re so much more than that. Our company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com A DAY IN THE LIFE: We are seeking a Manager, Compliance Engineering to lead compliance testing activities for a portfolio of innovative medical devices. This role is responsible for developing and executing compliance test strategies, managing product certification efforts, and ensuring products meet applicable safety, EMC, wireless, and regulatory requirements. As a key technical leader, you will work closely with Engineering, Quality, Regulatory Affairs, and external test laboratories to guide products from development through certification and commercialization. The ideal candidate combines strong technical expertise in medical device testing with the ability to lead teams, manage complex projects, and drive continuous improvement. The Manager, Compliance Engineering Drives Product Compliance Through Testing Excellence and is also responsible for; Lead compliance testing and certification activities for new products and product modifications. Develop compliance test strategies, plans, schedules, and resource requirements for product development programs. Oversee product testing related to safety, EMC, wireless, environmental, and other applicable regulatory requirements. Manage relationships with external test laboratories, certification bodies, and consultants, ensuring quality, cost, and schedule objectives are achieved. Review and approve test plans, protocols, reports, risk assessments, and certification documentation. Partner with Engineering teams to identify compliance risks early and drive effective testing and mitigation strategies. Support design reviews and risk management activities with a focus on product safety, performance, and regulatory compliance. Monitor changes in regulatory requirements and industry standards, assess impacts, and implement testing strategies to maintain compliance. Develop and improve compliance testing processes, tools, metrics, and best practices to increase efficiency and predictability. Lead, mentor, and develop a team of compliance engineers and test professionals. Manage departmental budgets and forecasting related to compliance testing, laboratory services, equipment, and resources. Ensure all activities are conducted in accordance with company policies and applicable quality, regulatory, privacy, and safety requirements. WHAT YOU’LL NEED: Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering or related technical discipline, or equivalent combination of education and applicable job experience. Advanced coursework, Master’s degree, or professional licensing in related field desirable. 5-8+ years of experience leading compliance testing, product certification, or regulatory engineering activities within the medical device industry. 5+ years of experience leading/supervising in a high volume, medical device, biotech, or pharmaceutical environment preferred. Strong knowledge of medical device safety and regulatory standards, including FDA QSR/QMSR, ISO 14971, and IEC 60601 series requirements. Experience managing external compliance testing laboratories and certification programs. Knowledge of EMC, electrical safety, wireless, and software/firmware compliance requirements for connected medical devices. Proven ability to lead technical teams and manage multiple compliance testing programs simultaneously. Experience with risk management, quality systems, GDP, and GMP requirements. Strong project management, communication, and stakeholder management skills. Demonstrated success driving process improvements and operational excellence within a testing or compliance organization. WHEN & WHERE YOU’LL WORK: Hybrid: This role will be a mix of in-office work at our corporate headquarters in Del Mar, CA and remote work. This position is expected to be in office 3+ days per week but may vary depending on business demands. COMPENSATION & BENEFITS: The starting base pay range for this position is $141,800.00 - $177,300.00 annually. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate’s location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes bonus and a robust benefits package. Tandem offers health care benefits such as medical, dental, vision available your first day, as well as health savings accounts and flexible saving accounts. You’ll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (with accrual starting on day 1) and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan. Learn more about Tandem’s benefits here! YOU SHOULD KNOW: Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information. Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders. SPONSORSHIP: Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. WHY YOU’LL LOVE WORKING HERE: At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at https://www.tandemdiabetes.com/careers. BE YOU, WITH US! We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don’t meet 100% of a job description’s criteria – maybe you’re feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us. Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone. REFERRALS: We love a good referral! If you know someone who would be a great fit for this position, please share! APPLICATION DEADLINE: The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications. Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow. #LI-Hybrid #LI-DW1