Sr. Mechanical Engineer

Medtronic•Lafayette, CO

10d•$106,400 - $159,600•Hybrid

About The Position

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.

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.
Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
May act as a mentor to colleagues or may direct the work of other lower level professionals.
The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

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)