Sr. Mechanical Engineer

## Sr. Mechanical Engineer
-Apply remote type:
Onsite locations:
Lafayette, Colorado, United States of America time type:
Full time posted on:
Posted Todaytime left to apply:
End Date:
July 13, 2026 (27 days left to apply) job requisition :
R69256

We anticipate the application window for this opening will close on - 13 Jul 2026

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.#
** 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 quality issues                                            

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 (Solid Works,…