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: Bachelor’s degree with 4+ years’ relevant experience, or Advanced degree with 2+ years of experience.