Sr. Mechanical Engineer -

We anticipate the application window for this opening will close on - 21 Aug 2026   Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life Job Title: Senior Mechanical Engineer (Medical Devices – Design & Sustaining Engineering) Location: [Lafayette, CO / Hybrid / Global] Employment Type: Fulltime ________________________________________ Position Summary We are looking for an experienced Senior Mechanical Engineer to support the design, development, and lifecycle management of medical devices in a highly regulated environment. This role will be responsible for delivering robust, compliant, and high-quality mechanical designs, ensuring adherence to FDA regulations, ISO 13485, and design control processes. The engineer will play a key role in both New Product Development (NPD/NPI) and Advanced Sustaining Engineering, driving product improvements, resolving field issues, and ensuring ongoing compliance. The ideal candidate brings a strong combination of technical depth, regulatory discipline, and cross-functional leadership, with experience navigating design control frameworks and supporting audits. ________________________________________ Key Responsibilities Design & Development (Design Controls) • Lead mechanical design activities in compliance with Design Control requirements (21 CFR Part 820 / ISO 13485) • Develop and maintain design documentation including: o Design inputs/outputs o Verification & validation plans/reports (DV/PV) o Design reviews o Traceability matrices (DHF) • Ensure alignment with User Needs, Intended Use, and Risk Management outputs ________________________________________ New Product Introduction (NPI) • Drive product development from concept through design transfer to manufacturing • Support prototype builds, design verification (DV), validation (PV), and clinical readiness • Collaborate with manufacturing and quality teams to ensure design for manufacturability (DFM) and scalability • Support process validation activities (IQ/OQ/PQ) ________________________________________ Sustaining Engineering & Post-Market Support • Lead root cause investigations (RCA) for product complaints, CAPAs, and non-conformances • Implement design changes through controlled Engineering Change Orders (ECOs) with full traceability • Support post-market surveillance, field issue resolution, and regulatory reporting inputs • Ensure continuous compliance of released products ________________________________________ Risk Management & Compliance • Lead and contribute to risk management activities per ISO 14971 (FMEA, hazard analysis, risk controls) • Ensure design solutions effectively mitigate patient and user risks • Support regulatory submissions (510(k), MDR, etc.) by providing design documentation • Participate in internal/external audits (FDA, notified bodies) and ensure audit readiness ________________________________________ Cost Optimization & VAVE • Drive Value Engineering / Cost Optimization initiatives while maintaining compliance and product performance • Evaluate alternate materials, components, and manufacturing processes with full regulatory impact assessment • Partner with sourcing and suppliers to implement cost reduction strategies ________________________________________ Supplier & Manufacturing Collaboration • Collaborate with global suppliers to ensure component quality and compliance • Support supplier qualification and design transfer activities • Partner with manufacturing sites to address design-related yield, reliability, and