Principal Quality Engineer – Medical Devices NPI & Scale-Up

MiniMed; San Diego (CA); On-site; USD 121,000 - 205,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) match

Short-term disability

Paid time off

Employee Stock Purchase

Employee Assistance

Daycare account

Job summary

MiniMed seeks a Principal Design Quality Engineer in California to oversee quality records for low- to mid-volume manufacturing and new product scale-up across multiple product platforms.

You will lead cross-functional teams, implement IQ/OQ/PQ/TMV strategies, apply DFSS/DFMA, and drive risk management with pFMEA and DOEs, while ensuring compliance with FDA QSR 21 CFR Part 820 and ISO 13485.

Qualifications

• Master's degree plus 5+ years experience in process development or manufacturing for medical devices.
• Or a Bachelor's degree with 7+ years experience in the same domain.
• 7+ years creating IQ/OQ/PQ/TMV strategies for medical devices.
• Knowledge of ISO 14971 and pFMEA; FDA QSR and ISO 13485.

Responsibilities

• Develop validation strategies for NPIs and scale-up.
• Author IQ/OQ/PQ/EQV/TMV documents.
• Apply DRM/DFSS/DFMA/COS methodologies.
• Lead PFMEA and root cause investigations.
• Coordinate with cross-functional teams for design transfer and manufacturing readiness.
• Drive risk mitigation and containment to protect launch timelines.
• Deploy SPC and DOEs to support decisions.

Skills

Medical devices

Root cause analysis

Statistical methods

Education

Master's degree in Mechanical/Biomedical Eng

Bachelor's degree in Mechanical/Biomedical Eng

Tools

Minitab

Job description

MiniMed seeks a Principal Design Quality Engineer in California to oversee quality records for low- to mid-volume manufacturing and new product scale-up across multiple product platforms.

You will lead cross-functional teams, implement IQ/OQ/PQ/TMV strategies, apply DFSS/DFMA, and drive risk management with pFMEA and DOEs, while ensuring compliance with FDA QSR 21 CFR Part 820 and ISO 13485.