Senior Manufacturing Quality Engineer

A growing medical device company based in the Los Angeles area is seeking a Senior Manufacturing Quality Engineer to support hardware quality across the product lifecycle. The company develops next-generation biometric sensor devices for hospital use and cloud-based clinical software solutions. This is a hands-on engineering role requiring direct involvement in device-level failure analysis, contract manufacturer (CMO) oversight, manufacturing process improvement, and product reliability enhancement.

The role owns the device hardware Risk Management File, leads manufacturing-related CAPA investigations, and serves as the primary quality engineering interface between the product development team and external CMOs. The position requires a strong hardware engineering foundation combined with applied quality systems expertise in an FDA-regulated medical device environment. This role will require working onsite 4-5 days/week at the LA office.

Key Responsibilities:

• Lead hardware product complaint investigations and failure analysis to determine root cause and implement corrective actions.
• Own and maintain the Risk Management File (RMF) throughout the product lifecycle in accordance with ISO 14971 and EU MDR Annex I.
• Execute risk management activities across the PDLC, including hazard analysis, risk evaluation, and mitigation during design, manufacturing, and post-market phases.
• Perform and document product risk assessments (DFMEA, UFMEA, HHE/HHA) and support development of risk management plans and reports.
• Ensure design control compliance (ISO 13485) with risk mitigations traceable across requirements, verification, and validation.
• Collaborate cross-functionally with engineering, manufacturing, quality, regulatory, marketing, and post-market teams to support design transfer and lifecycle risk management.
• Contribute to Technical File and Design History File documentation supporting EU MDR/CE Mark and FDA submissions.
• Develop and execute verification & validation (V&V) test plans, applying statistical methods (DOE, regression, capability analysis) to support reliability and test method validation.
• Support compliance with medical electrical safety standards (IEC 60601, IEC 61000) and participate in CAPA investigations, audits, and regulatory inspections.

Required Skills & Experience:

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, Industrial).
• 5+ years of quality engineering experience in an FDA-regulated, ISO 13485-certified medical device manufacturing environment, with direct involvement in hardware quality activities (failure analysis, CMO oversight, process validation, or design transfer).
• Demonstrated hands-on experience investigating hardware failures: device disassembly, measurement and inspection, fault isolation, and root cause determination. Proficiency with inspection tools and measurement equipment (e.g., calipers, microscopes, multimeters) in a manufacturing context is required.
• Proven experience managing the quality relationship with contract manufacturers (CMOs) — including supplier audits, process validation reviews, and corrective action management.
• Demonstrated ownership or significant contribution to a Risk Management File per ISO 14971:2019, including FMEA facilitation.
• Experience with design transfer activities: process capability review, component qualification, FAI, and DHR documentation.
• Working knowledge of 21 CFR 820, ISO 13485:2016, and EU MDR 2017/745.
• Proficiency with statistical tools (Minitab, JMP, or equivalent) for DOE, capability analysis, and test method validation.
• Experience leading or contributing to CAPA investigations with structured root cause analysis and verified corrective actions.
• Strong communication, documentation, and cross-functional collaboration skills, and willingness to travel domestically (<20%) to contract manufacturing sites.