Senior Design Quality Engineer – Medical Devices & NPI

USA-Medtronic MiniMed, Inc 1017; Los Angeles (CA); On-site; USD 121,000 - 205,000; Full time

Benefits offered by this job

Health, dental, & vision insurance

401(k) with company match

Employee Stock Purchase Plan

Paid time off & holidays

Flexible benefits

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 multiple platforms. You will lead process development, validation, and risk mitigation while partnering with cross-functional teams to drive robust, manufacturable designs.

The role requires strong expertise in pFMEA, design controls, and statistics (SPC, DOEs) with the ability to influence decisions and ensure regulatory

Qualifications

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

Responsibilities

• Develop validation strategies and DOE plans for NPI and scale-up projects.
• Lead risk management activities including pFMEA and design risk assessment with cross-functional teams.
• Collaborate with R&D, supplier quality, and NPI groups to transfer designs to manufacturable processes and ensure first-pass yields.
• Perform statistical analyses and generate process capability reports to support production readiness.

Skills

Process Development

Risk Management

Cross-functional Collaboration

Statistical Analysis

Education

Master's degree in Mechanical or Biomedical Eng

Bachelor's degree in Mechanical or Biomedical Eng

Tools

Minitab

DFSS/DFMA knowledge

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 multiple platforms. You will lead process development, validation, and risk mitigation while partnering with cross-functional teams to drive robust, manufacturable designs.

The role requires strong expertise in pFMEA, design controls, and statistics (SPC, DOEs) with the ability to influence decisions and ensure regulatory