Sr. Mechanical Engineer -

Medtronic • Lafayette, CO

11d • $106,400 - $159,600 • Hybrid

About The Position

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.

Requirements

• 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: FDA 21 CFR Part 820, ISO 13485 Quality Management Systems, 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 analysis
• Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

• Experience with Class II / Class III medical devices
• Familiarity with electro-mechanical systems, enclosures, plastics, and precision components
• Experience supporting regulatory submissions (510(k), CE Marking, MDR)
• Working knowledge of FEA/thermal analysis tools
• Proven success in driving VAVE/cost savings initiatives ($1M+ impact preferred)
• Experience working across global manufacturing and supplier ecosystems

Responsibilities

• Lead mechanical design activities in compliance with Design Control requirements (21 CFR Part 820 / ISO 13485)
• Develop and maintain design documentation including: Design inputs/outputs, Verification & validation plans/reports (DV/PV), Design reviews, Traceability matrices (DHF)
• Ensure alignment with User Needs, Intended Use, and Risk Management outputs
• 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)
• 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
• 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
• 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
• 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
• Researches, plans, designs, verifies, validates and develops mechanical and/or electromechanical products and systems, such as metals, instruments, controls, plastics, robots, engines, machines and mechanical, resonance, hydraulic or heat transfer systems for production, transmission, measurement, and use of energy.
• Recommends various technology options or approaches for system, processes, facility or program improvements in terms of safety, performance, efficiency or costs.
• May be responsible for the transfer from R&D to manufacturing.

Benefits

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior