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
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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.
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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
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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)
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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
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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
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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
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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 quality issues
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Required Qualifications
• Bachelor’s or Master’s degree in Mechanical Engineering or related field
• 4–6+ years of experience in medical device product development or regulated industries
• Strong working knowledge of:
o FDA 21 CFR Part 820
o ISO 13485 Quality Management Systems
o ISO 14971 Risk Management
• Proven experience with design controls and DHF documentation
• Expertise in CAD tools (SolidWorks, Creo, NX, or equivalent)
• Hands-on experience with NPI, design transfer, and sustaining engineering
• Strong experience in root cause analysis (RCA), CAPA, and failure analys