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Description: About AEMI AEMI, an AEM company, is a leading manufacturer of high-reliability electronic components specializing in circuit protection, power conditioning, and radio frequency (RF) components. With a solid global presence, AEMI serves mission-critical industries such as aerospace and defense and the industrial and automotive sectors. Our commitment to innovation and quality has positioned us as a preferred supplier for highly engineered solutions in harsh environments. Position Summary The Test Engineer is responsible for planning, executing, and documenting electrical screening and qualification tests for electronic components and devices. This role involves electrical characterization, parametric measurement, functional validation, and the application of reliability-related electrical stresses. The Test Engineer ensures that all components meet defined performance, quality, and reliability requirements by developing robust test plans, performing hands-on testing, analyzing results, and generating clear technical reports. In addition, the Test Engineer is responsible for reviewing customer Purchase Orders (POs) to ensure that all components are routed through the correct handling, screening, and manufacturing processes required to meet test and reliability standards. Essential Duties & Responsibilities: Review customer Purchase Orders (POs) to determine required testing, handling, and screening for manufacturing. Perform electrical screening tests on electronic components (active and passives components) Conduct parametric measurements (resistance, capacitance, inductance, etc.) Identify out-of-spec components, early failures, or marginal performance Support development of electrical screening criteria and limits Develop and execute electrical qualification test plans based on industry standards (JEDEC, AEC-Q, MIL-STD, etc.) Perform electrical stress tests such as burn-in and thermal shock Verify electrical performance over voltage and temperature ranges Analyze electrical test data, trends, and variability Perform statistical analysis (e.g., Cp/Cpk, distributions, limit setting) Create clear, comprehensive test reports summarizing methods, results, and recommendations Review supplier datasheets and specifications for electrical performance compliance Assist in root-cause analysis for electrical failures during development or production Organizational Overview AEM, headquartered in San Diego, California, is a portfolio company of Industrial Growth Partners (IGP), a private equity firm focused exclusively on middle-market industrial manufacturing and niche services businesses. Through its industry leading brands AEM, Renaissance Electronics, and Central Semiconductor, AEM serves niche applications across a diverse array of attractive markets including satellite, aerospace, defense, industrial, medical, EV/Battery, and telecom. AEM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability. Requirements: Minimum Qualifications: Bachelor’s degree in electrical engineering or related field. Minimum of 2 years of experience with electrical testing, device characterization, or component qualification. Strong understanding of electronic component and device operation and electrical behavior. Hands-on experience with lab instrumentation. Familiarity with electrical qualification standards (JEDEC, AEC-Q, MIL-STD). Preferred Qualifications Knowledge of ESD/latch-up qualification practices. Experience supporting component failure analysis from an electrical perspective. Background in aerospace or high-reliability electronics. Physical Qualifications: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties and responsibilities of this job. As a routine part of work, employees will generally be required to use their hands to manipulate, handle, or feel objects, tools (including small tools) or controls; reach with hands and arms; climb stairs; sit and stand for long periods of time; and talk and hear. Specific vision abilities include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
Job Summary: The primary responsibility is to perform mechanical and visual inspections of raw materials, products, and assemblies to defined specifications. Essential Job Duties and Responsibilities: Ensure product meets defined specifications by performing dimensional and visual inspection of product according to established inspection processes. Assure the proper handling, inspection, status identification and release of product are performed according to applicable procedures. Ensure that product moves in an un-interrupted flow to meet processing and/or delivery schedules. Initiate and process Non-Conformance Reports, as necessary. Review production documentation for accuracy and completeness. Interact with Operations personnel to ensure product is inspected and moved to the next operation efficiently and accurately. Use company software to ensure accuracy and movement of product. Use of calibrated equipment to perform inspections. Lot History Record (LHR) review. Interact with Operations personnel to determine the status and potential release date of product. Work with Operations to resolve quality issues. Job duties are not limited to the areas of responsibility listed above. Specific responsibilities may be modified and additional responsibilities may be assigned which are in line with the job summary at the discretion of company management. Education, Experience, Skills, & Abilities: Excellent organization skills and attention to detail Previous cGMP/ISO experience a plus Previous inspection experience in a regulated industry a plus Ability to use basic measuring equipment (caliper, micrometer, microscope, gages, etc.) Able to read, interpret and understand technical drawings and specifications Working knowledge of Windows applications (WORD, Outlook, Excel) Clear written and verbal communication skills Physical Requirements: Ability to sit, use hands and fingers, talk or hear, and smell continually. Ability to stand, walk and reach frequently. Ability to climb or balance, stoop, kneel, or crouch occasionally. Ability to frequently lift and carry up to 10 lbs. and occasionally lift and carry up to 30 lbs. Close vision required to see computer monitor, read documents, and operate copy and fax machine. Distance vision required to drive an automobile, if driving is a requirement of the job. Work environment is indoors and climate controlled. Occasionally exposed to outdoor weather conditions. Moderate noise levels as found in a business office with computer printers, households with TVs and dishwashers, and driving light traffic.
Tempo Communications is a leading designer and manufacturer of test and measurement instruments for the global telecommunications industry. Our product portfolio spans fiber optic test equipment, copper network analyzers, cable locators, and installation tools trusted by field technicians, network engineers, and service providers worldwide. We are committed to engineering excellence, continuous innovation, and delivering reliable solutions that keep the world connected. We are seeking an experienced Senior Manufacturing Engineer to join our Fiber Optic Test Equipment product line. In this role, you will serve as the technical authority for optical characterization processes and fiber test methodologies on the manufacturing floor. You will collaborate closely with R&D, Quality, and Production teams to transition new fiber test products from development into high-volume manufacturing, ensure ongoing process integrity, and drive continuous improvement initiatives that enhance yield, throughput, and measurement accuracy. Optical & Fiber Test Engineering Define, develop, and validate manufacturing test processes for fiber optic products, including OPM (Optical Power Meter), SLS (Stabilized Light Source), OLTS (Optical Loss Test Set), VFL (Visual Fault Finder), and OTDRs (Optical Time Domain Reflectometer). Establish test limits, acceptance criteria, and measurement uncertainty budgets for all fiber-related production tests, ensuring compliance with industry standards (TIA, IEC, ITU-T). Design, specify, and qualify production test fixtures and automated optical test stations; oversee calibration, traceability, and maintenance programs for all fiber test equipment on the floor. Develop and maintain Manufacturing Test Procedures (MTPs) and Test Plans for fiber products; ensure documentation is current and accessible to production and quality teams. Investigate and resolve measurement anomalies, test escapes, and optical performance failures, using root cause analysis tools (8D, Ishikawa, FMEA) to drive permanent corrective actions. New Product Introduction (NPI) Partner with R&D and Product Line Management during design phases to provide Design for Manufacturability (DFM) and Design for Testability (DFT) input specific to fiber optic assemblies and electro-optical subsystems. Lead the manufacturing readiness review process for new fiber test products, including process FMEA, control plan development, and first article inspection coordination. Create production Work Instructions according to assembly requirements specified in released documentation. Establish and maintain Key Performance Indicators (KPI) for critical optical parameters; develop SPC monitoring plans for ongoing production. Continuous Improvement & Production Support Identify and lead yield improvement projects for fiber optic assemblies and electro-optical subassemblies; use data-driven analysis to reduce test cycle times and non-conformance rates. Support failure analysis of returned fiber test instruments; provide technical input to engineering and QA departments. Maintain strong working knowledge of current fiber test equipment technologies (OTDRs, optical power meters, light sources, VFLs) and track emerging industry standards that may impact test requirements. Provide technical mentorship and training to manufacturing technicians on fiber test methodologies, handling procedures for fiber-optic connectors and assemblies, and safe laser operation practices. Bachelor’s degree in Electrical Engineering, Mechanical Engineering, Optical Engineering, Physics, or a closely related technical discipline. 5–15 years of manufacturing engineering experience with a strong focus on fiber optic test equipment, electro-optical systems, or photonics instrumentation. Deep hands-on expertise with fiber test instrumentation. Demonstrated experience interpreting and applying fiber optic test standards: TIA-568, TIA-526, IEC 61300 series, and ITU-T G.650/G.651/G.652. Proficiency with statistical process control (SPC), measurement systems analysis (MSA/Gauge R&R), and DOE methodologies applied to optical measurement processes. Experience developing automated test systems using LabVIEW, Python, or equivalent test automation frameworks; familiarity with instrument control via GPIB, USB-TMC, or Ethernet (SCPI/VISA). Demonstrated ability to write clear, thorough engineering documentation: process specifications, test procedures, control plans, and failure analysis reports. Working knowledge of fiber optic connector types (LC, SC, FC, MPO/MTP), connector polish types (PC, UPC, APC), and fiber types (SMF, MMF, PM fiber). Strong analytical and troubleshooting skills; experience with root cause analysis methodologies such as 8D, 5-Why, and fishbone analysis.
About Artiva: Artiva is clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artiva’s lead program, AlloNK®, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjögren’s Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artiva’s pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell’s NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California. For more information, visit www.artivabio.com. Job Summary The Manufacturing Associate will support manufacturing of Artiva’s off-the-shelf cell therapy platforms in our new, state of the art, cGMP facility. The successful candidate will develop and adhere to written procedures (SOPs) related to GMP facility operations, monitoring of equipment and facilities, and manufacturing of cell therapies internally at Artiva. The ideal candidate will demonstrate in-depth knowledge of cGMP compliance and will support manufacturing activities across multiple programs. Duties/Responsibilities Assist in setting up cGMP manufacturing suites and equipment/fixtures as needed. Perform facility and equipment monitoring activities. Assist in authoring manufacturing standard operating procedures and batch production records that are technically sound, promote effective and efficient operations, and comply with cGMP requirements. Perform cGMP manufacturing and support operations described in standard operating procedures and batch records across multiple programs. Complete documentation required by process tech-transfer protocols, validation protocols, standard operating procedures, and batch records following cGDP standards. Perform tasks in a manner consistent with Artiva’s safety policies, quality systems, and GMP requirements. Complete training assignments and qualifications to ensure the necessary GMP manufacturing, and process related technical skills and knowledge. Required Skills & Experience Bachelor’s degree in relevant science or engineering discipline, or equivalent work experience. Minimum 2 years of experience in cGMP biologics or cell culture manufacturing, experience in biotech or cell therapy manufacturing preferred. Experience in the following preferred: Aseptic gowning and manufacturing in an ISO 7 clean room environment. Cell counting on various platforms Cell culture and expansion using bag systems, single use large scale bioreactors, and others where applicable. Sartorius systems experience a plus. Experience with transduction using Lentiviral vectors Cell harvesting and washing processes both automated and manual. Experience with kSep a plus. Cell selection and depletion techniques using Miltenyi CliniMACS Prodigy. Fill finish and Cryopreservation processes and equipment in both bags and vials. AT-vialing a plus Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. Working Conditions and Physical Requirements Will require working with cells and cell lines of human origin as well as viral vectors Position may require occasional weekend or evening work at Artiva. Why you should apply: We have a fantastic team and philosophy! We are passionate – We deeply care about our team, our science, and improving the lives of autoimmune and cancer patients. We are tenacious – we are laser-focused on our mission and undeterred in our commitment to make cell therapies broadly accessible to patients with autoimmune disease and cancer. We are innovative - pushing into new frontiers for patient benefit. We are transparent - believers in flat, accessible, and open communication paths. We are inclusive – committed to the diversity of our team and ensuring that all voices are heard. In addition to a great culture, we offer: · An entrepreneurial, highly collaborative, and innovative environment · Comprehensive benefits, including: Medical, Dental, and Vision Group Life Insurance Long Term Disability (LTD) 401(k) Retirement Plan Employee Assistance Program (EAP) Flexible Spending Account (FSA) Paid Time Off (PTO) Company paid holidays, including the year-end holiday week Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey! Base Salary: $75,000 - $105,000. Exact compensation may vary based on level, skills and experience. Location San Diego, CA Employment Type
About Tempo Communications Tempo Communications is a leading designer and manufacturer of test and measurement instruments for the global telecommunications industry. Our product portfolio spans fiber optic test equipment, copper network analyzers, cable locators, and installation tools trusted by field technicians, network engineers, and service providers worldwide. We are committed to engineering excellence, continuous innovation, and delivering reliable solutions that keep the world connected. Position Summary We are seeking an experienced Senior Manufacturing Engineer to join our Fiber Optic Test Equipment product line. In this role, you will serve as the technical authority for optical characterization processes and fiber test methodologies on the manufacturing floor. You will collaborate closely with R&D, Quality, and Production teams to transition new fiber test products from development into high-volume manufacturing, ensure ongoing process integrity, and drive continuous improvement initiatives that enhance yield, throughput, and measurement accuracy. Key Responsibilities Optical & Fiber Test Engineering Define, develop, and validate manufacturing test processes for fiber optic products, including OPM (Optical Power Meter), SLS (Stabilized Light Source), OLTS (Optical Loss Test Set), VFL (Visual Fault Finder), and OTDRs (Optical Time Domain Reflectometer). Establish test limits, acceptance criteria, and measurement uncertainty budgets for all fiber-related production tests, ensuring compliance with industry standards (TIA, IEC, ITU-T). Design, specify, and qualify production test fixtures and automated optical test stations; oversee calibration, traceability, and maintenance programs for all fiber test equipment on the floor. Develop and maintain Manufacturing Test Procedures (MTPs) and Test Plans for fiber products; ensure documentation is current and accessible to production and quality teams. Investigate and resolve measurement anomalies, test escapes, and optical performance failures, using root cause analysis tools (8D, Ishikawa, FMEA) to drive permanent corrective actions. New Product Introduction (NPI) Partner with R&D and Product Line Management during design phases to provide Design for Manufacturability (DFM) and Design for Testability (DFT) input specific to fiber optic assemblies and electro-optical subsystems. Lead the manufacturing readiness review process for new fiber test products, including process FMEA, control plan development, and first article inspection coordination. Create production Work Instructions according to assembly requirements specified in released documentation. Establish and maintain Key Performance Indicators (KPI) for critical optical parameters; develop SPC monitoring plans for ongoing production. Continuous Improvement & Production Support Identify and lead yield improvement projects for fiber optic assemblies and electro-optical subassemblies; use data-driven analysis to reduce test cycle times and non-conformance rates. Support failure analysis of returned fiber test instruments; provide technical input to engineering and QA departments. Maintain strong working knowledge of current fiber test equipment technologies (OTDRs, optical power meters, light sources, VFLs) and track emerging industry standards that may impact test requirements. Provide technical mentorship and training to manufacturing technicians on fiber test methodologies, handling procedures for fiber-optic connectors and assemblies, and safe laser operation practices. Required Qualifications Bachelor’s degree in Electrical Engineering, Mechanical Engineering, Optical Engineering, Physics, or a closely related technical discipline. 5–15 years of manufacturing engineering experience with a strong focus on fiber optic test equipment, electro-optical systems, or photonics instrumentation. Deep hands-on expertise with fiber test instrumentation. Demonstrated experience interpreting and applying fiber optic test standards: TIA-568, TIA-526, IEC 61300 series, and ITU-T G.650/G.651/G.652. Proficiency with statistical process control (SPC), measurement systems analysis (MSA/Gauge R&R), and DOE methodologies applied to optical measurement processes. Experience developing automated test systems using LabVIEW, Python, or equivalent test automation frameworks; familiarity with instrument control via GPIB, USB-TMC, or Ethernet (SCPI/VISA). Demonstrated ability to write clear, thorough engineering documentation: process specifications, test procedures, control plans, and failure analysis reports. Working knowledge of fiber optic connector types (LC, SC, FC, MPO/MTP), connector polish types (PC, UPC, APC), and fiber types (SMF, MMF, PM fiber). Strong analytical and troubleshooting skills; experience with root cause analysis methodologies such as 8D, 5-Why, and fishbone analysis.
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