Senior Quality Engineer - Process Development

About the role

We anticipate the application window for this opening will close on 10 Jul 2026. At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

Responsibilities

• Process Development & Validation
  • Develop P-diagrams, Input-Process-Output (IPO) matrices, process characterizations, and test method validation (TMV) strategies for NPI programs.
    • Author and manage Master Validation documents (IQ/OQ/PQ/EQV/TMV) for new product introductions and production scale-up.
      • Apply methodologies including Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly (DFMA), and Cell Operating System (COS).
      • Drive risk mitigation approaches by integrating qualification parts early in process development phases.
• Process Risk Management & Risk Navigation
  • Facilitate and generate Process Failure Modes Effects Analysis (PFMEA) documents for manufacturing processes during NPI and scale-up.
    • Maintain strong working knowledge of design risk documentation (RAD, DFMEA, HRA) to critically analyze process-related failures and identify gaps.
      • Recognize when process findings have design risk implications and escalate appropriately to Design Quality Assurance (DQA) partners for design risk assessment decisions.
      • Leverage understanding of risk documentation during root cause investigations and critical analyses to ensure comprehensive disposition.
  • Conduct thorough root cause investigations using A3 Problem Solving methodology, fishbone diagrams, 5-Why analysis, and brainstorming techniques.
• Cross-Functional Engagement & Collaboration
  • Serve as the primary quality interface between internal Supplier Quality Engineering (SQE), R&D cross-functional teams, Contract Manufacturers, and NPI program teams.
    • Facilitate regular cadence of alignment discussions with Supplier Quality and vendors to implement updated control plans, inspection criteria, and risk documentation.
    • Collaborate with R&D teams to translate design intent into manufacturable process parameters during design transfer.
    • Partner with NPI groups to ensure seamless transition from development builds through production qualification and commercial readiness.
    • Ensure alignment between contract manufacturers and internal teams on deliverables, expectations, and quality standards.
    • Bridge QMS gaps between contract manufacturing partners and internal quality systems, standardizing documentation templates and expectations.
    • Direct comprehensive drawing reviews with cross-functional partners ensuring all Critical Dimensions are accounted for incoming and in-process inspections.
• Production Scale-Up Support & Crisis Management
  • Lead cross-functional teams through high-pressure production holds and scale-up challenges during NPI commercialization.
    • Conduct root cause investigations (A3 methodology) and implement Corrective and Preventive Actions (CAPA).
    • Strategize and guide engineering teams to deploy effective investigation approaches for supplier and manufacturing issues.
    • Proactively identify production risks during scale-up and drive containment/resolution before they impact launch timelines.
  • Statistical Analysis & Data-Driven Decision Making
    • Perform statistical analyses including hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, and GR&R using Minitab.
      • Utilize statistical process control (SPC), I-MR charts, Box plots, and Normality & Non-Normal tests to make quality decisions.
      • Leverage data-driven approaches to inform process development decisions and validate process characterizations.
      • Generate process capability reports to support production readiness decisions.

Must Have

• Minimum Requirements
  • To be considered for this role, please ensure the minimum requirements are evident on your resume.
  • A Bachelor’s degree with 4+ years’ relevant experience, or an Advanced degree with 2+ years of experience.

Physical Job Requirements

While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers.

Benefits & Compensation

MiniMed offers a competitive salary and flexible benefits package. For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $97,000 - $165,000 USD. Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Short Term Incentive (STI)

This position is eligible for a short-term incentive called the Short Term Incentive (STI).

About MiniMed

MiniMed is a full-stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey — when and how they need it. For more than 40 years, we’ve been committed to redefining what’s possible: intelligent dosing systems designed for real life, predictive insights that stay a step ahead, and always on support when it’s needed most. At the heart of everything we do is a simple Mission: to make every day a better day for people with diabetes.