Principal Quality Engineer – Medical Devices, Process

MiniMed Group; Los Angeles (CA); On-site; USD 121,000 - 205,000; Full time

Job summary

MiniMed is seeking a Principal Quality Engineer - Process Development to lead validation and process development across multiple product platforms. The role requires ensuring SOP adherence while driving cross-functional alignment and rapid issue resolution.

You will author Master Validation documents, apply DRM/DFSS/DFMA, and manage pFMEA to mitigate process risks in NPI and scale-up. Strong collaboration with R&D and supplier quality is essential.

Qualifications

• Master's degree in Mechanical Engineering, Biomedical Engineering, or related field with 5+ years in process development or manufacturing for medical devices.
• Bachelor's degree in Mechanical/Biomedical Engineering or related field with 7+ years in process development or manufacturing for medical devices.
• 7+ years creating or overseeing IQ/OQ/PQ/TMV strategies for medical devices.
• Mastery of ISO 14971 and pFMEA with a track record linking process risks to design controls.
• Strong knowledge of statistical methods (DOEs, capability studies, Gage R&R) in manufacturing.
• Solid knowledge of FDA QSR (21 CFR Part 820) and ISO 13485.
• CQE or Six Sigma Black Belt certification.

Responsibilities

• Develop validation strategies for NPI programs and production scale-up.
• Author and manage Master Validation documents (IQ/OQ/PQ/EQV/TMV).
• Apply DRM, DFSS, DFMA, and COS methodologies in projects.
• Lead pFMEA and root cause investigations across processes.
• Coordinate with cross-functional teams for design transfer to manufacturing.
• Review drawings with cross-functional partners to ensure critical dimensions are captured.

Skills

Statistical methods (DOEs, Gage R&R,能力

Education

Master's degree in Mechanical/Biomedical Engineering or related field

Bachelor's degree in Mechanical/Biomedical Engineering or related field

Tools

Minitab

pFMEA

DFSS/DFMA/DRM

FDA QSR 21 CFR Part 820 & ISO 13485

Job description

MiniMed is seeking a Principal Quality Engineer - Process Development to lead validation and process development across multiple product platforms. The role requires ensuring SOP adherence while driving cross-functional alignment and rapid issue resolution.

You will author Master Validation documents, apply DRM/DFSS/DFMA, and manage pFMEA to mitigate process risks in NPI and scale-up. Strong collaboration with R&D and supplier quality is essential.