Quality Engineering Leader - Medical Devices & NPI

USA-MiniMed Distribution Corp. 1018; Los Angeles (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

MiniMed is seeking a Principal Design Quality Engineer to oversee quality records and strategy for low to mid-volume manufacturing lines and new product scale-up across various product platforms. You will influence cross-functional teams and ensure operations align with SOPs while maintaining pragmatism.

The role requires expertise in DFSS/DFMA, pFMEA, and data analytics to support production readiness and launch timelines, with a strong focus on risk mitigation and design transfer.

Qualifications

• Master's degree in Mechanical or Biomedical Engineering with 5+ years in process development or manufacturing for medical devices.
• Or Bachelor's degree in Mechanical or Biomedical Engineering with 7+ years in process development or manufacturing for medical devices.
• Experience with ISO 14971, pFMEA, FDA QSR and ISO 13485 is preferred.

Responsibilities

• Develop and validate processes for NPI programs and production scale-up, including IQ/OQ/PQ/EQV/TMV.
• Lead risk management, DFx methodologies, and supplier quality collaboration to ensure robust design transfer.
• Perform statistical analyses (DOE, SPC, GR&R) and generate process capability reports to support readiness.

Skills

Quality engineering

Cross-functional collaboration

Statistical analysis

Root cause analysis

Process validation

Education

Master's degree in Mechanical or Biomedical Engineering

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

Minitab

Job description

MiniMed is seeking a Principal Design Quality Engineer to oversee quality records and strategy for low to mid-volume manufacturing lines and new product scale-up across various product platforms. You will influence cross-functional teams and ensure operations align with SOPs while maintaining pragmatism.

The role requires expertise in DFSS/DFMA, pFMEA, and data analytics to support production readiness and launch timelines, with a strong focus on risk mitigation and design transfer.