Lead Quality Engineer, Medical Devices & NPI Scale-Up

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

Job summary

MiniMed is seeking a Principal Design Quality Engineer to lead quality strategy for low-to-mid-volume manufacturing and product scale-up across multiple platforms in the United States. You will partner with cross-functional teams to ensure compliant, reliable processes and products throughout development and production.

The role focuses on risk-based design quality, process validation, and continuous improvement, with extensive exposure to medical device regulatory requirements and

Qualifications

• Master's degree in Mechanical Engineering, Biomedical Engineering, or related field and 5+ years in process development/manufacturing engineering for medical devices.
• Bachelor's degree in Mechanical/Biomedical Engineering or related field and 7+ years in process development/manufacturing engineering for medical devices.

Responsibilities

• Develop P-diagrams, IP-OQ-PQ validation strategies for NPI programs.
• Author and manage Master Validation documents (IQ/OQ/PQ/EQV/TMV) for new product introductions and scale-up.
• Apply DRM, DFSS, DFMA, COS methodologies in development.
• Drive risk mitigation by integrating qualification parts early in development.
• Facilitate pFMEA documents for manufacturing processes during NPI/scale-up.
• Analyze design risk documentation and escalate when necessary to Design Quality Assurance partners.
• Lead root cause investigations using A3, fishbone, 5-Why techniques.
• Collaborate with suppliers and vendors to update control plans and inspection criteria.
• Translate design intent to manufacturable process parameters during design transfer.
• Direct drawing reviews ensuring Critical Dimensions are accounted for in inspections.
• Guide cross-functional teams through production holds and scale-up during NPI commercialization.
• Develop and apply investigation approaches for supplier/manufacturing issues.

Education

Master's/Bachelor's in Engineering

Engineering degree + 7+ years

Job description

MiniMed is seeking a Principal Design Quality Engineer to lead quality strategy for low-to-mid-volume manufacturing and product scale-up across multiple platforms in the United States. You will partner with cross-functional teams to ensure compliant, reliable processes and products throughout development and production.

The role focuses on risk-based design quality, process validation, and continuous improvement, with extensive exposure to medical device regulatory requirements and