Principal Quality Engineer - Process Development

We anticipate the application window for this opening will close on - 9 Nov 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. About the Role This Principal Design Quality Engineer will oversee quality records and strategy for low to mid-volume manufacturing lines and new product scale-up across various product platforms. Success in this role requires a high degree of professional discretion to ensure teams operate in accordance with standard operating procedures while maintaining a pragmatic, collaborative approach. Sitting squarely at the intersection of multiple cross-functional groups, you must act as a trusted partner and influencer who clears roadblocks and builds alignment. Key Responsibilities Process Development & Validation Develop P-diagrams, Input-Process-Output matrices, process characterizations, and test method validation 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) to critically analyze process-related failures and identify gaps. Recognize when process findings have design risk implications and elevate appropriately to Design Quality Assurance 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 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. Direct comprehensive drawing reviews with cross-functional partners ensuring all Critical Dimensions are accounted for incoming and in-process inspections. Lead cross-functional teams through high-pressure production holds and scale-up challenges during NPI commercialization. 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 Education & Experience Required Master's degree in Mechanical Engineering, Biomedical Engineering, or related field AND 5+ years of experience in process development or manufacturing engineering for medical devices OR Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related engineering field AND 7+ years of experience in process development or manufacturing engineering for medical devices Highly Desired Qualifications 7+ years creating and/or overseeing complex IQ/OQ/PQ and TMV strategies for medical devices. Mastery of ISO 14971 and pFMEA with a clear track record of linking process risks to design controls. Strong working knowledge of statistical methods (DOEs, capability studies, Gage R&R) used in manufacturing. Solid working knowledge of FDA QSR (21 CFR Part 820) and ISO 13485. Demonstrated experience exercising high-level professional discretion, influencing cross-functional peers, and guiding technical root cause investigations. Demonstrated experience in supporting low-to mid-volume electromechanical production lines or wearable medical devices. CQE (Certified Quality Engineer) or Six Sigma Black Belt certification Physical Job Requirements The abov #J-18808-Ljbffr