design-transfer jobs in San Diego

Sr QA Engineer leading complex quality investigations, root cause analysis, CAPAs, and NCMRs at a regulated medical device company (Dexcom). Drives Quality Management System excellence through continuous improvement methodologies (Six Sigma, Lean, process capability analysis), owns validation and qualification strategies for equipment/processes/software, and guides design transfer and commercialization from development to high-volume manufacturing.…See more Requires advanced quality engineering knowledge, hands-on technical aptitude, proficiency with data analysis tools (JMP, Excel), and cross-functional leadership across R&D, Regulatory, Manufacturing, and Engineering teams.

As a Development Sr Engineer II, you will serve as a design owner and project manager for new medical device product design, development, and commercialization in the orthopedic/arthroplasty space. You will translate user needs from surgeons into design requirements, create CAD models and design documentation, conduct design verification/validation testing, and support regulatory and manufacturing teams through product launch.…See more The role demands expertise in parametric CAD modeling, finite element analysis, design of experiments, and medical device regulations and standards.

Staff QA Engineer role at Dexcom leading quality engineering for high-volume manufacturing automation, design control, and process validation. Responsibilities include interpreting FDA 21 CFR 820 and ISO 13485 requirements, architecting validation strategies, driving design transfer for commercial deployment, leading complex investigations and CAPA initiatives, and mentoring cross-functional teams.…See more Requires deep expertise in root cause analysis, Six Sigma, process validation, statistical analysis, and data-driven decision-making across global sites.

Sr Staff QA Engineer at Dexcom leading Design Quality Engineering for material characterization, formulation science, and material-related risk management across product lifecycle. Responsibilities include establishing traceability between material attributes and device performance, leading qualification strategies for polymers, enzymes, reagents, adhesives, coatings, and membranes, applying ISO 14971 risk management, and partnering with R&D, Materials Science, Analytical Chemistry, Process Development, Manufacturing, and Regulatory Affairs.…See more Requires 8+ years in medical device, pharmaceutical, biotechnology, or combination product development with deep expertise in material characterization, analytical chemistry, and formulation development.

Sr Staff QA Engineer at Dexcom leads Design Quality Engineering for material characterization, formulation science, and material-related risk management across product development and lifecycle management. The role requires deep expertise in characterizing complex material systems (polymers, enzymes, reagents, adhesives, coatings, membranes) and establishing traceability between material attributes, manufacturing processes, and finished device safety/performance.…See more Responsibilities include driving risk-based decision making using ISO 14971, overseeing qualification strategies, partnering with R&D and regulatory teams, and representing Design Quality in design reviews, audits, and regulatory submissions. Requires 8+ years in medical device, pharmaceutical, or biotechnology quality engineering with demonstrated experience in material characterization and design control processes.

Lead complex quality investigations and root cause analysis for a medical device company, driving CAPAs, NCMRs, and systemic corrective actions. Provide technical leadership in quality engineering methodologies including Six Sigma, Lean Manufacturing, process capability analysis, and risk-based problem solving.…See more Own validation and qualification strategies for equipment, processes, test methods, and software V&V across the product lifecycle. Partner with R&D, Regulatory Affairs, Manufacturing, and Engineering teams on design transfer, commercialization, and compliance initiatives while representing Quality during audits and regulatory inspections.

Staff Engineer responsible for developing and implementing scalable engineering systems, processes, and operating models to improve collaboration between product development and operations. The role requires applying robust engineering methodologies (DFM, DFA, DOE, DFSS, Lean Product Development) and systems thinking to solve complex organizational challenges while driving continuous improvement and manufacturing readiness.…See more Success demands the ability to influence cross-functional teams without direct authority, use data-driven decision-making, and coach others to build organizational capability across technical and business functions.

Staff QA Engineer at Dexcom leading manufacturing quality and regulatory compliance for continuous glucose monitoring devices. Responsibilities include directing Design Control and design transfer strategy, managing process validation and commercialization, leading cross-functional teams on complex technical and compliance matters, and providing expert guidance on Quality Management System governance (FMEA, CAPA, process controls).…See more Requires deep hands-on experience with FDA 21 CFR 820, ISO 13485, and related QMS requirements, plus ability to mentor teams and represent the organization during audits and regulatory inspections.