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Department: Assembly - Fabrication - Metal Fabrication - AME - Layout Reports To: Manager/Supervisor Position Type: Onsite - Full-time [40 hours per week] Shift Hours: First 6:00 am - 2:30 pm, Second Shift 2:30 pm - 11:00 pm Hourly Rate: $19 - $30 based on experience Position Description: We are seeking a motivated and skilled Metal Fabrication Technician to join our team. In this role, you will be responsible for cutting, machining, bending, fabricating, welding, and assembling metal components with precision and efficiency. Your expertise will contribute to the production of durable, high-quality metal parts that meet strict industry standards. Responsibilities: Read and interpret detailed blueprints, schematics, and technical drawings to guide fabrication processes. Operate various power tools, hand tools, punch press, waterjet, laser, press brake machines, and machining equipment to shape and assemble sheet metal components. Perform MIG (Metal Inert Gas), TIG (Tungsten Inert Gas) welding to join metal parts securely. Use calipers, micrometers, and other precision measurement tools to ensure parts meet exact specifications Minimum Qualifications: Ability to read and follow written instructions Ability to speak, read, and neatly write English Ability to read blueprints, schematics, and technical drawings accurately. Proficiency in using calipers, micrometers, hand tools, power tools, press brake machines, and other fabrication equipment. Mechanical knowledge related to manufacturing processes Basic math skills for measurements and calculations during fabrication tasks. Ability to work together as part of a team under limited supervision or independently Beneficial Skills and Experience: Basic computer skills Required Internal Training: HCI Orientation All pertaining process procedures that relate to job function Required Education: High School Diploma or equivalent Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is regularly required to walk, stand, and sit. The employee is frequently required to use hand to finger, handle, or feel objects, and tools. The employee is required to frequently reach with hands and arms, manipulate parts in repetitive motions; stoop, kneel; and talk to hear. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or up to 50 pounds. Specific vision abilities required by this job include close vision, peripheral vision, depth perceptions, and the ability to adjust focus. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is regularly exposed to vibration. The employee occasionally works near moving mechanical parts and in high, precarious places and is occasionally exposed to the risk of electrical shock. The noise level in the work environment is usually very loud. IMPORTANT: If offer of employment is made it will be contingent upon passing all of the following: E-Verify, Background Check, ITAR and U.S. Export Compliance Screening. Access to our facility (and, therefore, employment) is restricted under the International Traffic in Arms Regulations (ITAR) and/or Export Administration Regulations (EAR) to U.S. Citizens, lawful permanent residents, U.S. refugees, asylees or temporary residents under amnesty provisions [as defined in 8 USC 1324b(a)(3)] and properly licensed foreign persons. Additionally, potential employee’s names will be screened against the Consolidated Screening List (maintained by the United States government) to determine eligibility to receive technical data. Hughes Circuits is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, veteran status, disability, sexual orientation, or gender identity. Applicants apply online or in person Hughes Circuits Inc., 546 S. Pacific St San Marcos, CA 92078
Position Summary: The Quality Engineer is responsible for interpreting Customer contract requirements, engineering drawings & data sets, specifications, and other technical information to ensure compliance and proper implementation in the Quality Management System (QMS). Essential Duties and Responsibilities: Reviews design plans, process procedures, test procedures, and quality manuals to understand the scope, requirements, and function of products. Ensures products meet the organization's and customers' quality and product integrity requirements. Identifies root causes of problems in the production process; recommends and/or implements corrective measures. Analyzes data to identify trends in product quality or defects with the goal of mitigating and preventing recurrence and future defects. Provide interface to the Customer for quality related activities. Host and provide support for customer or industry quality audit or certification activities as well as support internal and or customer audits. Update and maintain procedures and work instructions to ensure compliance with Customer requirements. Conduct process and product audits in support of quality compliance. Participate in design review, design verification, and Integrated Product Team (IPT) support, as required. Create inspection plans, and methods for the manufacturing operations, including inspection equipment and tools necessary to provide efficient inspection processes. Assist and train personnel in procedures and processes establishing and documenting inspection criteria and process improvements including process auditing. Participate in and lead team based corrective action and continuous improvement efforts related to continuous quality improvement. Required participation in internal training as needed to perform the duties assigned to this role. May be assigned to manage MRB cage and process. May be assigned to project management programs that have significant quality requirements. Interact with customer and government inspectors. Visit suppliers and customers < 5%. Other related duties may be assigned. Requirements: Minimum Qualifications (Knowledge, Skills and Abilities) U.S. Person status required do to export control Bachelor's Degree in engineering or related field, or combination of education and work experience within the aerospace industry 1-2 years of AS9100 experience required Capable of standing and or sitting for extended periods of time Ability to communicate effectively with coworkers and the management team. Must be well organized, flexible, and able to work in a fast-paced manufacturing environment Must thrive in a team-oriented and deadline-driven environment Excellent organizational skills and attention to detail. Extensive knowledge of or the ability to quickly learn the organization's production processes. Certification to the Body of Knowledge for ASQ Quality Engineering preferred AS9000/AS9100 Auditing experience highly preferred Experience in performing root cause analysis and corrective action development Strong analytical and problem-solving skills. Experience with inspections tools and Romer-arm / CMM preferred. Highly skilled in MS Office programs- Excel, Word, Outlook, Power Point and Adobe Acrobat Familiarity and skill with interpreting technical drawings and blueprints Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made. While performing the duties of this job, the employee is regularly required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. Constant specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. The employee may occasionally lift and /or move up to 25 pounds. The employee sits for extended periods of time at a computer station or work desk and is exposed to typical office environment conditions and noise levels. Required to wear Personal Protective Equipment (PPE) when working on the manufacturing floor where the employee may be exposed to moving mechanical parts and is occasionally exposed to high, precarious places; fumes or airborne particles; outside weather conditions; extreme heat and risk of electrical shock. The noise level in the manufacturing floor is usually loud. Note: This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills aptitudes and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship. The Company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable. This position falls under the International Traffic in Arm Regulation (ITAR). This role is restricted to U.S. persons (i.e., U.S. citizens, permanent residents, and other protected individuals under the Immigration and Naturalization Act, 8 U.S.C. 1324b (a) (3)) due to access to export-controlled technology. Company will require proof of status prior to employment. Pay Transparency In order to support the Fair Compensation Strategy by the US Govt., HR Dept., clients are required to adhere to "Pay Transparency Law"; in the impacted states; that have mandated the employers to list the salary ranges in Job advertisements or postings for job opportunities and Job promotions.
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Post Market Quality Case Handling and Affiliate Support department is the Center of Excellence for the resolution of global product complaints. The Scientist is responsible for effective and timely resolution of global cases, including complaint investigations, risk assessments, case documentation, trending analysis and preparing reports, ensuring regulatory compliance and optimal levels of customer satisfaction. Also participates in the On-Boarding of new employees by providing product and process training and support. The ideal candidate has strong technical knowledge, expertise of assay workflow and system functionality, enjoys troubleshooting, and has a problem solving mindset. The Opportunity • You are responsible for handling complaints specific to the GenMark portfolio and are accountable for the timely handling of individual cases (Inquiry, Complaint, Potential Reportable and Safety issues) according to ISO Quality System requirements, regulations, and the needs of Country Organizations, including creation, acceptance, classification, investigation, complete documentation, on-site troubleshooting, and resolution. • You are responsible for experimental design of complaint investigations, conducting investigation experiments, and analyzing data using statistical measures for determining a potential product performance issue. • You assume responsibility to ensure, by collaborating and interfacing with the BA and global functions, that appropriate measures from cases are derived, including, but not limited to workarounds, in a timely manner. • You initiate, monitor, and ensure completion of complaint CAPAs and trigger appropriate preventive actions resulting from complaints. • You provide information from cases in order to update product documentation. • You assume responsibility for timely communication of quality-related information to the Country Organizations and for regular peer review of escalated cases. • You support initiatives and measures to maintain enhanced interfaces with country organizations and regional representatives while providing audit and inspection support as requested. • You contribute to the creation of regular reports to document on-market product quality and performance, escalate critical issues to the responsible Life Cycle Teams, define proactive measures, and perform case-related trending to understand the scope of an issue. • You support regular review of quality of case handling and CAPA management, analyzing feedback on customer satisfaction to permanently optimize processes with a focus on customer, compliance, and continuous improvement. • You assume responsibility to ensure risk assessments for product quality issues are complete and may be responsible for training and mentoring new employees and other team members. Who You Are • You hold a Bachelor’s degree in Life Science, Engineering, or a Related Field. • You have 2+ years of related work experience in a technical product support role, research and development setting, technical customer support role, or related function. • You are proficient in technical writing. • You possess Root Cause analysis knowledge. • You are computer literate, with knowledge of e-learning and multimedia technologies. • You have a demonstrated analytical, solutions-oriented, and collaborative approach to problem solving, with attention to details, technical orientation, excellent organization skills, solid troubleshooting capabilities, and a negotiation attitude. • You have knowledge of regulations and IVD standards, and Good Manufacturing Practices (GMP). Preferred • You have a background in Molecular Biology, Microbiology, Genomics, NextGen Sequencing, Chemistry, or a related field. • You have experience with Molecular Biology techniques including PCR technology. • You have knowledge of varied regulatory requirements and quality practices, especially in the area of complaint management (e.g., 21 CFR 820.198, ISO 10002, ISO 9001, ISO 13485). • Knowledge of additional languages a plus. Knowledge, Skills and Abilities • You have experience working with global cross-functional teams, or similar. • You possess solid communication skills (written and spoken) in English, which are essential. • You have very good presentation and communication skills. • You exhibit genuine empathy, patience, flexibility, and the ability to skillfully direct contacts to resolve issues in a timely manner. • You possess problem solving and troubleshooting capabilities. • You are a customer advocate with a business orientation. Locations This is a primarily onsite position based in Carlsbad, California, or Branchburg, New Jersey. Relocation benefits are not available for this position. The expected salary range for this position based on the primary location of Carlsbad is $63,900 to $118,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Who we are GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark’s ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California. GenMark is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this formAccommodations for Applicants.
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 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. Would you like to join us in this mission? Seeking a motivated leader with an Operational Excellence (OE) mindset to drive OE initiatives at our cancer immunotherapy viral vector manufacturing site in Oceanside, CA (MVP01). This role is part of the company-wide OE Network and will lead the development and implementation of OE programs across Technical Operations locally and throughout the network. The OE Senior Manager plays a critical role in driving meaningful change by working directly with stakeholders, employees, and processes to embed a culture of excellence through hands on engagement and continuous improvement. The Senior Manager demonstrates experience in applying continuous improvement techniques and producing results for functions, while assessing current business performance against Kite Pharma’s business plan for a specific site and/or function. The Senior Manager partners with cross-functional teams to analyze findings, recommend improvements, and lead strategic continuous improvement initiatives. This role also trains staff and leaders to foster a culture of continuous improvement and reports to the Associate Director of Business Strategy & Operations. Please note: This an onsite role Key Responsibilities of the Senior Manager of Operational Excellence include: Lead the development and execution of OE strategies to meet site goals, track progress, and escalate risks or barriers to success. Lead and coach teams in Lean methodologies including PDCA, DMAIC, root cause analysis, FMEA, Kaizen, and mistake-proofing. Develop strategic and tactical plans, KPIs, and dashboards to measure and advance MVP01’s OE program. Build and maintain a pipeline of improvement initiatives through strong cross-functional partnerships across Manufacturing, F&E, Quality, Supply Chain, and MSAT. Translate operational requirements into actionable improvement plans, ensuring alignment with site and network goals. Identify and prioritize improvement opportunities by evaluating processes for waste, cost savings, benefit realization, complexity, and inefficiency. Ensure continuous improvement initiatives and site processes apply appropriate Lean/Six Sigma tools, track benefits, and celebrate success to reinforce a culture of excellence. Facilitate Lean leadership behaviors and daily management routines, including visual management and tiered accountability structures. Own and continuously improve the site’s Tiered Meeting Structure, ensuring effective use of SQDEP metrics to drive performance, escalate issues, and foster accountability. Assess when changes are needed to enhance clarity, flow, and impact of tier meetings. Go to the work (Gemba) to observe, engage, and assess operational challenges firsthand, applying Lean principles to identify opportunities for efficiency, flow, and problem-solving. Guide teams in implementing practical solutions that align with OE best practices such as 5S/6S, visual management, and standard work. Conduct Lean Maturity assessments and develop roadmaps for measurable improvement. Serve as a change agent by mentoring leaders and teams, fostering servant leadership, representing the site within the network, and driving adoption of OE principles. Build trust and credibility across all levels of the organization by demonstrating emotional intelligence, active listening, and a collaborative approach to problem-solving. Thrive in a dynamic, fast-paced manufacturing environment by managing multiple priorities, navigating ambiguity, and driving results under pressure. Ensure sustainability of OE initiatives by embedding problem-solving capabilities and Lean thinking into daily operations and team behaviors. Promote knowledge sharing and adoption of best practices across the site and broader manufacturing network. Basic Qualifications: Doctorate OR Master’s degree with 0+ years of Operational Excellence and/or Strategy and/or Operations experience OR Master’s degree with 6+ years of Operational Excellence and/or Strategy and/or Operations experience OR Bachelor’s degree with 8+ years of Operational Excellence and/or Strategy and/or Operations experience OR Associate degree with 10+ years of Operational Excellence and/or Strategy and/or Operations experience OR High School Diploma / GED with 12+ years of Operational Excellence and/or Strategy and/or Operations experience Preferred Qualifications: 6+ years of Operational Excellence process improvement experience in a GMP regulated biotech or pharmaceutical manufacturing environment, ideally involving viral vector production or cell therapy operations. Proven track record of leading Operational Excellence initiatives in a complex manufacturing setting, with measurable impact on throughput, yield, and compliance. Deep understanding of manufacturing processes, quality systems, and regulatory requirements. Lean Six Sigma certification (Black Belt or Kaizen Leader) with demonstrated application of tools such as DMAIC, PDCA, FMEA, and root cause analysis in a manufacturing context. Experience implementing and sustaining Lean Daily Management systems, including tiered accountability, visual management, and standard work in a production environment. Strong facilitation and coaching skills with the ability to train manufacturing teams and leaders in OE methodologies and drive cultural transformation. Ability to navigate between strategic planning and hands-on problem solving. Demonstrated success in leading cross-functional improvement projects involving Manufacturing, F&E, Quality, Supply Chain, and Technical Operations. Proficiency in data analysis and performance tracking using tools such as Excel, Power BI, Smartsheet, and other digital OE platforms. Excellent communication and stakeholder engagement skills, with the ability to influence at all levels of the organization. Proactive and self-directed leader who consistently seeks out improvement opportunities and takes initiative without waiting for direction to implement impactful solutions. The salary range for this position is: $153,935.00 - $199,210.00. 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.
The Senior Engineer, Catheter NPI & Manufacturing is responsible for leading the transfer, scale-up, and commercialization of catheter-based medical devices to contract manufacturers (CMOs) for Arga Medtech Inc. This role ensures successful externalization of manufacturing through robust design transfer, process validation, and supplier integration. Develops technical solutions to complex manufacturing challenges and works cross-functionally to ensure CMOs are fully capable, qualified, and scalable for commercial production. *ESSENTIAL DUTIES AND RESPONSIBILITIES:* Design Transfer & CMO Externalization * Lead end-to-end transfer of catheter products from R&D to established contract manufacturers, including planning, execution, and post-transfer stabilization. * Develop and own comprehensive technology transfer packages (process flows, BOMs, work instructions, equipment specifications, test methods, and training materials). * Ensure full alignment between DHF and DMR, with clear translation of design outputs into manufacturable specifications at the CMO. * Define transfer strategy including build plan (alpha, pilot, validation, ramp) and success criteria. * Establish manufacturing equivalency between internal development builds and CMO production. Manufacturing Fixture & Tooling Development * Design, develop, and qualify custom manufacturing fixtures and tooling to support catheter assembly processes (e.g., bonding, alignment, tipping, reflow). * Translate process requirements into fixture design specifications, including tolerance stack-ups, alignment constraints, thermal considerations, and operator interaction. * Develop rapid prototype fixtures (e.g., 3D printed, machined) to support engineering builds and process development. * Collaborate with internal teams and/or CMOs to transition prototype fixtures into production-ready tooling. * Generate and maintain fixture documentation packages (drawings, BOMs, work instructions, maintenance requirements). * Ensure fixtures are scalable, repeatable, and suitable for transfer to manufacturing environments. CMO Readiness & Qualification Execution * Partner with Supply Chain and Quality to support CMO onboarding and qualification activities. * Execute technical capability assessments and gap closure plans for assigned CMOs. * Define equipment, tooling, and infrastructure requirements to enable successful transfer. * Support first article inspection (FAI) and process qualification readiness. * Ensure CMO alignment with FDA QSR, ISO 13485, and internal quality requirements. Process Development, Industrialization & Validation * Transfer and scale catheter manufacturing processes (e.g., bonding, shaft assembly, tipping, coating, extrusion interfaces) to CMO environments. · Author and execute protocols and reports for design verification & design validation activities. This includes shelf-life packaging testing, product functionality and performance testing. * Author and execute process validation (IQ/OQ/PQ) at the CMO, including protocol development, execution oversight, and report approval. * Develop and industrialize catheter manufacturing processes, including design and integration of fixtures and tooling required to ensure repeatability and scalability. * Incorporate fixtures into process validation activities (IQ/OQ/PQ), ensuring they are qualified and capable of consistently meeting process requirements. * Define and monitor critical process parameters (CPPs) and critical quality attributes (CQAs). * Ensure appropriate process controls, in-line inspection methods, and SPC systems are implemented at the CMO. * Drive process robustness and repeatability across sites. Build Execution & Production Ramp * Plan and execute engineering builds, pilot builds, and validation builds at the CMO. * Transfer fixture designs and tooling requirements to contract manufacturers, ensuring accurate replication and implementation. * Provide on-site technical support during builds, including troubleshooting and operator training. * Establish yield targets, scrap reduction plans, and ramp metrics. * Drive resolution of build issues through structured root cause analysis (DOE, 5-Why, Fishbone). * Transition ownership to sustaining teams post-launch with clear handoff criteria. Supplier & CMO Performance Management * Serve as primary technical interface between Arga and CMO engineering/manufacturing teams. * Establish and monitor KPIs (yield, cycle time, cost, quality) for CMO performance. * Lead continuous improvement and value engineering initiatives with CMOs. * Support and resolve NCR, CAPA, and deviation investigations related to CMO production. * Drive change management (ECO/ECN) implementation across internal and external stakeholders. Cross-Functional Leadership & Compliance * Partner with Quality, Regulatory, and Supply Chain to ensure compliant and efficient product transfer. * Support regulatory submissions and audits related to manufacturing transfer or process changes. * Lead risk management activities (PFMEA, control plans) specific to CMO processes. * Ensure all activities meet design control and quality system requirements. Documentation & Systems * Develop and maintain DMR, process documentation, work instructions, and training materials at the CMO. * Ensure traceability between design requirements, process controls, and inspection methods. * Review and approve CMO-generated documentation for alignment with product requirements. *EXPERIENCE & QUALIFICATIONS:* · Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering, or related field, or equivalent experience. · 10+ years of experience in medical device engineering with strong emphasis on NPI, design transfer, and CMO execution. · Proven track record of successful product transfer to contract manufacturers, including validation and commercial ramp. · Deep expertise in catheter manufacturing processes and materials. · Proven experience designing and implementing fixture-driven process solutions for catheter or complex assembly manufacturing. · Strong experience with process validation (IQ/OQ/PQ), DOE, SPC, and statistical methods. · Experience working with global CMOs and supplier networks. · Working knowledge of CAD tools including experience with SolidWorks. · Strong understanding of FDA QSR, ISO 13485, and regulatory expectations. · Strong understanding of ISO 10555-1. · Experience supporting regulatory submissions, audits, and inspections related to manufacturing sites. · Demonstrated leadership in cross-functional and matrixed environments. · Experience managing engineers or technical teams preferred. Pay: From $120,000.00 per year Benefits: * 401(k) * Health insurance * Paid time off Application Question(s): * What is your desired salary? * How many years of experience in medical device engineering with emphasis on NPI, Design transfer, and CMO execution do you have? * How many years have you worked with catheters? Work Location: In person
*Job Overview* We seek a motivated and detail-oriented individual to join our team as a skilled woodworker. We are willing to train the right candidate on the specifications of our product. We are looking for an individual with a strong work ethic, mechanical aptitude, commitment to quality craftsmanship who loves the ocean! *Duties* * Construct spearguns for the free-diving industry. * Utilize hand and power tools for the cutting, shaping, and assembling the finished product. * Assemble the speargun from the raw material to the customized final product. * Follow production standards while adhering to safety protocols. * Maintain a clean and organized work environment throughout the project duration. *Skills* * Strong knowledge of woodworking techniques and materials is preferred but not required. * Experience with physical labor associated with woodworking tasks. * Familiarity with various carpentry skills such as cutting, sanding, and measuring. * Previous custom woodworking experience is highly desirable. * Excellent problem-solving skills with attention to detail in all aspects of work. * Knowledge of water damage restoration techniques including mold remediation and structural drying processes. * Familiarity with schematics related to electrical systems or plumbing as they pertain to cabinetry or fixture installation. * Strong understanding of construction site safety standards along with experience working on diverse construction sites or manufacturing environments. * Excellent problem-solving skills combined with the ability to read technical drawings accurately for efficient project completion. Join us if you’re passionate about woodworking excellence! We value craftsmanship that combines precision with creativity—delivering outstanding results that transform spaces and restore structures with care and expertise. If you are passionate about woodworking and possess the necessary skills to excel at this role, we invite you to apply. Join us in creating high-quality spearguns that stand the test of time! Pay: $20.00 - $26.00 per hour Benefits: * Tools provided Work Location: In person
General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as advanced high-resolution surveillance systems. Under general direction, this position is responsible for designing and fabricating minor metal parts, tools and jigs through precision work on original and intricate layout, machining and assembly tasks. Performs tasks with some detailed instructions and intermittent review of work. Welds, lathes, heats, cuts, bends, solders, and drills from detailed descriptions. Sets up and operates precision tools. DUTIES & RESPONSIBILITIES Assists in designing and building production tooling for fabricated parts. Performs prototype fabrication from detailed instruction, visual descriptions or sketches. Forms sheet metal parts using brakes, shears, notchers and presses. Runs manual mills, lathes, drill presses and grinding equipment to perform turning, facing, boring, chamfering, drilling, grooving, reaming, tapping and slotting. Sets up and operates a variety of engine lathes to perform quantity production machining to close tolerances. Programs and runs prototrak mill. Grinds own cutting tools, drills and bits. Designs and builds jigs and fixtures for producing weldments and dip brazing. Designs and builds press tooling for forming sheet metal parts. Performs plumbing operations using AN fittings with hard and flexible lines. Performs welding, fitting and soldering on extremely thin ferrous and non-ferrous metals. Utilizes blue prints, sketches, drawings, verbal descriptions and sample parts to determine dimensions and tolerances of finished parts, the sequence of operations, and set up requirements. Responsible for observing all laws, regulations, and other applicable obligations wherever and whenever business is conducted on behalf of the Company. Expected to work in a safe manner in accordance with established operating procedures and practices. Performs preventive maintenance and makes adjustments as required. Other duties as assigned or required. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. Job Qualifications Typically requires an associate's degree, certification or equivalent in a related discipline and two or more years experience in fabrication. Requires good knowledge of fabrication policies and procedures. Must have ability to read and understand technical instructions, drawings and specifications and utilize basic equipment. Must be able to respond to non-routine issues or situations and contribute to the solutions of routine issues. Must be able to weld to close tolerances and have working knowledge of AN and MS fasteners, AN plumbing and aircraft riveting tools. Must have basic computer applications skills pertinent to the field, and have the skills necessary to precisely record technical data. Ability to work in a team in a team environment is essential as is the ability to work extended hours as required. Job Category Manufacturing Experience Level Entry-Level (0-2 years) Workstyle Onsite Full-Time/Part-Time Full-Time Hourly Pay Range Low 52,020 Pay Range High 77,325 Travel Percentage Required 0% - 25% Relocation Assistance Provided? No US Citizenship Required? Yes Clearance Required? No
General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as advanced high-resolution surveillance systems. We have an exciting opportunity for a FAI Process Administrator to join our Quality team in Poway. The FAI Process Administrator owns and continuously improves the First Article Inspection (FAI) process within an aerospace manufacturing environment. This role ensures compliance with AS9102, customer, and regulatory requirements while driving efficiency, transparency, and innovation. Serving as the central coordinator for FAI documentation, training, governance, metrics, and strategy, the role partners cross-functionally from shop floor to leadership. Key responsibilities include developing and executing a multi-year strategic roadmap incorporating digital tools, AI, Cpk, and process improvements. DUTIES AND RESPONSIBILITIES: FAI Process Ownership Own and administer GA-ASI FAI process across programs, and sites. Act as FAI subject matter expert and ensure AS9102 and customer compliance. Coordinate FAI execution across Engineering, Manufacturing, Quality, Supply Chain, and Programs. Documentation & Training Develop and maintain FAI procedures, templates, and work instructions. Lead documentation reviews and updates based on audits and lessons learned. Design and deliver FAI training and partner with Learning teams to ensure compliance. Metrics & Process Efficiency Define and manage KPIs for FAI quality, cycle time, and effectiveness. Create dashboards, analyze trends, and lead data-driven improvements. Strategy & Innovation Own a three-year FAI strategic roadmap aligned with business objectives. Identify and pilot AI, automation, and digital inspection solutions. Support change management for new tools and methodologies. Communication & Engagement Communicate FAI status, risks, and improvements clearly to stakeholders. Facilitate cross-functional alignment and problem solving. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. Job Qualifications Typically requires a bachelor's or master's degree in engineering or related discipline and five or more years of related experience with a bachelor's degree or three or more years with a master's degree. May substitute equivalent experience in lieu of education. Strong knowledge of AS9102 and FAI requirements in regulated manufacturing. Experience with process documentation, training, metrics, and leadership presentations. Ability to read engineering drawings and GD&T (ASME Y14.5). Knowledge of manufacturing, inspection methods, and special processes. Experience with FAI package review (internal and supplier). Familiarity with inspection tools (CMMs, calipers, optical comparators) and calibration. Understanding of AS9100, audits, corrective action, and root cause analysis. Proficiency with data analysis tools and digital systems (QMS, PLM, MES). Knowledge of continuous improvement, Lean/Six Sigma, and process automation. Excellent communication and collaboration skills. Preferred Qualifications & Competencies Experience leading quality or inspection processes. Exposure to AI, digital quality systems, or advanced inspection technologies. Project management or continuous improvement experience. Strategic and analytical thinking. Change management and influence. Strong organization and communication skills. Ability to translate complex requirements into execution. Job Category Quality Experience Level Mid-Level (3-7 years) Workstyle Onsite Full-Time/Part-Time Full-Time Salary Pay Range Low 81,080 Pay Range High 141,650 Travel Percentage Required 0% - 25% Relocation Assistance Provided? No US Citizenship Required? Yes Clearance Required? No
General Atomics Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a world leader in proven, reliable remotely piloted aircraft and tactical reconnaissance radars, as well as advanced high-resolution surveillance systems. We have an exciting opportunity for a 2nd shift Manufacturing Engineer to join our manufacturing team in Poway, CA. Under general supervision and with on-going review, this position supports the engineering staff in the analysis, investigation and resolution of routine engineering problems of limited scope. Assignments are for small projects or phase(s) of larger projects(s) and are normally outlined in terms of specific engineering activities. Contributes to the completion of assigned engineering tasks which involve the exercise of independent judgment and discretion about matters of significance. Documents findings and implemented solutions, and communicates results to project engineering staff. Contacts are primarily internal within the team. May provide direction to design staff or technicians. This position is for the second shift. DUTIES AND RESPONSIBILITIES: Determines technical objectives for solution(s) to advanced technical engineering problems. Represents the organization as a prime technical contact within and engineering team for assigned project(s)/program(s). May function in an advisory or leadership role for a project/program and provide direction and guidance to less experienced professional staff or team of manufacturing personnel. Formulates plans and guides the development and implementation of engineering solution(s) including deployment, resource requirements, testing requirements and equipment selection, documentation, integration and compliance and safety. Plans and coordinates the maintenance of engineering solutions including, documentation, reporting, publishing, and making technical and other presentations to ensure viability of the solution(s) in an evolving environment. Plans for future applications of solutions based on new developments in engineering technology. Participates in or may lead the development of new or expansion of existing business opportunities. Maintains the strict confidentiality of sensitive information. Performs other duties as assigned. Responsible for observing all laws, regulations and other applicable obligations wherever and whenever business is conducted on behalf of the Company. Expected to work in a safe manner in accordance with established operating procedures and practices. Engineering requirements would be applicable to both product design as well as manufacturing process design and development with an emphasis on the latter. Experience with production, procurement, and quality processes in support to pre-production as well as supporting existing production. Develop and execute introduction to production plans including but no limited to production workflows, Point of manufacturing, production test procedures and quality inspection plans. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. Job Qualifications Typically requires a bachelors degree in engineering or a related technical discipline from an accredited institution. May substitute equivalent engineering experience in lieu of education. Must have a basic understanding of engineering concepts, principles, and theory. Demonstrates a detailed and extensive technical expertise and application of engineering principles, concepts, theory, and practice with the ability to organize, plan, schedule, conduct, and coordinate workloads to meet established deadlines or milestones with some experience in project leadership. Must possess the ability to understand new concepts quickly and apply them accurately throughout an evolving environment; strong communication, presentation, and interpersonal skills to effectively interface with other departments, customers, government representatives, and/or professionals; the capability of representing the organization as a prime technical contact; and, the ability to provide leadership and guidance to less experienced professionals. Must be customer focused and able to work on a self- initiated basis or in a team environment and able to work extended hours and travel as required. Professional Engineering License, original work(s) published in professional engineering journals, invited to present one or more original works to an engineering symposium, and invited and/or participated on an engineering review panel are desirable. Experience on Video systems and testing, RF/Antenna systems, RF Test equipment performance and use with a thorough knowledge of transmitters and receivers – radar experience a plus. A thorough understanding of lean and the ability to think and drive beyond current technology to positively affect cost, quality and reliability. Desired to have experience with RF, System Integration & Test, SAP. Must have thorough understanding of Manufacturing concepts and principles. Experience with New product introduction, LRIP, and Full rate production) Experience with mechanical 3D design and printing of production tooling, shop aids. Experience with system programing language. Job Category Engineering Experience Level Entry-Level (0-2 years) Workstyle Onsite Full-Time/Part-Time Full-Time Salary Pay Range Low 62,510 Pay Range High 105,628 Travel Percentage Required 0% - 25% Relocation Assistance Provided? No US Citizenship Required? Yes Clearance Required? No
*Role Overview* We are seeking a hands-on *Test Engineer* to design, develop, and scale production test systems for advanced battery products used in *medical, industrial, and high-reliability applications*. This role sits at the intersection of *product development and manufacturing*, ensuring that every product shipped meets performance, safety, and regulatory requirements. You will play a critical role in *New Product Introduction (NPI)* and *production optimization*, building robust test solutions that improve yield, reduce cycle time, and support compliance in regulated environments. *Production Test Development & NPI* · Design and implement *automated production test systems* for battery modules and electronic assemblies (analog, power, digital) · Develop *test hardware, fixtures, and software* to support scalable manufacturing · Partner with design engineering to ensure *Design for Test (DFT)* is embedded early in development · Lead test readiness for *new product launches*, ensuring smooth transition into production *Sustaining Engineering & Continuous Improvement* · Troubleshoot production test failures and *drive root cause analysis and CAPA* · Improve test efficiency by reducing *cycle time, false failures, and operator variability* · Maintain and enhance existing test systems to support product changes and reliability improvements · Support MRB and drive resolution of non-conforming product *Technical Execution* · Debug circuits and systems down to the *component level* · Develop and maintain: o Test plans and procedures o Test fixture schematics and BOMs o Test software and automation scripts o Data collection and traceability systems · Perform calibration and validation of test systems to *NIST standards* *Regulatory & Quality Support* · Ensure test systems and processes support compliance with: o *ISO 13485 / 14971* o *IEC 60601 (medical electrical systems)* o CE and other applicable standards · Support internal and external audits, including FDA and customer audits · Work cross-functionally with Quality, Manufacturing, and Program Management to ensure alignment *Education & Core Experience* · B.S. Electrical Engineering or similar Technical Degree with focus on electronic theory and software/firmware development · 5+ years developing *automated production test systems* in electronics or battery-related industries · Strong experience with *hardware + software integration for test* · Proven ability to troubleshoot complex systems in a *manufacturing environment* *Technical Skills & Industry Experience* · Programming experience in one or more: o *Python, C#, LabVIEW, or VB.NET* · Experience with: o Gauge R&R, PPAP/PPQ Validations o 1D and 2D Data Matrix barcodes, labeling and traceability o Data acquisition and test automation o Power electronics and embedded systems testing · Familiarity with: o Test fixtures, jigs, and instrumentation o Optical or advanced measurement systems · Experience in regulated environments (medical devices strongly preferred) · Familiarity with battery systems, BMS, or energy storage products · Understanding of ECO/ECN processes and change control *What Makes You Successful in This Role* · You think like an owner—focused on *yield, throughput, and product quality* · You are equally comfortable *writing code and debugging hardware* · You proactively identify gaps and drive *practical, scalable solutions* · You communicate clearly across engineering, manufacturing, and quality teams *Physical & Work Environment* · Hands-on lab and production environment · Frequent use of electronic test equipment and small tools · Combination of bench work, computer-based development, and production floor support Pay: $85,000.00 - $122,000.00 per year Benefits: * 401(k) * 401(k) matching * Dental insurance * Health insurance * Health savings account * Life insurance * Paid time off * Referral program * Tuition reimbursement * Vision insurance Work Location: In person
The Cabinet Maker is responsible for fabricating a variety of millwork materials from start to finish with precision and thoroughness, ensuring jobs are completed on schedule and within budget. Job Responsibilities: * Measure, cut, drill, nail and assemble materials to job specifications * Display refined cabinetry and finish carpentry skills * Able to read blueprints and knowledgeable in cabinet assembly, hardware, installation, and layout * Proficient with carpentry hand tools and machinery such as table saws, edge bander and drill press * Follow safety protocols to ensure a safe working environment for yourself and others * Demonstrate general safety knowledge, wearing proper safety equipment, using tools safely and remains accident-free * Ensure the proper assembly of materials while keeping the workspace clean and organized * Other projects and tasks assigned as needed Qualifications and Skills: * At least 3 years of cabinet making experience required * Ability to manage and prioritize multiple tasks to complete projects on time * Strong attention to detail and ability to troubleshoot problems * Proficient in math skills including adding, subtracting, multiplication and division, calculating square footage of materials * Lift up to 50 pounds for extended periods, kneeling, bending, standing, climbing, and repetitive motion * English language fluency and comprehension required Education and Requirements: * High School Diploma - or the equivalent (for example, GED) Work Hours and Benefits: * Monday to Friday, 7:00 AM to 3:30 PM * Full-time, Nonexempt * Retirement plan eligibility following probationary period * Paid holidays and paid vacation time Pay: $23.00 - $26.00 per hour Benefits: * 401(k) * 401(k) matching * Cell phone reimbursement * Paid time off Work Location: In person
*Job Overview* We are seeking a dynamic and detail-oriented Machine Shop Assistant Manager / Programmer to join our manufacturing team. This role combines leadership, technical expertise, and hands-on machining skills to ensure efficient production processes and high-quality output. As a key member of our shop, you will assist with overseeing daily operations, coordinate machining activities, and develop precise programming for various CNC machines. Your mechanical knowledge and manufacturing experience will drive continuous improvement, safety, and excellence in our machining operations. This is an exciting opportunity for someone passionate about manufacturing technology and team leadership to make a significant impact. *Responsibilities* * Lead daily machine shop operations, ensuring safety protocols, quality standards, and production deadlines are met efficiently. * Program CNC milling machines, lathes, and other equipment using CAM software and G-code to produce complex parts with precision. * Read and interpret detailed blueprints, GD&T (Geometric Dimensioning & Tolerancing), and technical drawings to ensure accurate manufacturing. * Operate and maintain CNC equipment * Supervise shop personnel, assign tasks, monitor workflow, and provide mentorship to improve skills and productivity. * inventory management within the warehouse environment. * Implement lean manufacturing principles to optimize processes, reduce waste, and improve overall efficiency. *Requirements* * Proven experience with CNC programming (including CNC milling machines and CNC lathes), CAM programming software, and G-code development. * Strong mechanical knowledge with hands-on experience in machining * Ability to read blueprints accurately and apply GD&T standards for precision manufacturing. * Familiarity with programmable logic controllers (PLCs) used in automation processes. * Skilled in using precision measuring instruments such as micrometers and calipers for quality control inspections. * Experience operating forklifts and warehouse equipment is a plus. * Knowledge of lean manufacturing practices to streamline operations effectively. * Excellent problem-solving skills with attention to detail in a fast-paced environment. * Basic math skills necessary for measurement calculations and process adjustments. * Strong communication skills for team coordination and documentation purposes. Join us if you're eager to lead a high-performing machine shop team while leveraging your technical expertise in CNC programming, fabrication, welding, and manufacturing! Pay: $35.00 - $40.00 per hour Benefits: * 401(k) * 401(k) 5% Match * 401(k) matching * Dental insurance * Health insurance * Life insurance * Paid time off * Vision insurance People with a criminal record are encouraged to apply Work Location: In person