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
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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________________________________________
New Product Introduction (NPI)
Drive product development from concept through design transfer to manufacturingSupport prototype builds, design verification (DV), validation (PV), and clinical readinessCollaborate with manufacturing and quality teams to ensure design for manufacturability (DFM) and scalabilitySupport process validation activities (IQ/OQ/PQ)________________________________________
Sustaining Engineering & Post-Market Support
Lead root cause investigations (RCA) for product complaints, CAPAs, and non-conformancesImplement design changes through controlled Engineering Change Orders (ECOs) with full traceabilitySupport post-market surveillance, field issue resolution, and regulatory reporting inputsEnsure 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 risksSupport regulatory submissions (510(k), MDR, etc.) by providing design documentationParticipate 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 performanceEvaluate alternate materials, components, and manufacturing processes with full regulatory impact assessmentPartner with sourcing and suppliers to implement cost reduction strategies________________________________________
Supplier & Manufacturing Collaboration
Collaborate with global suppliers to ensure component quality and complianceSupport supplier qualification and design transfer activitiesPartner 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 field4–6+ years of experience in medical device product development or regulated industriesStrong 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 documentationExpertise in CAD tools (SolidWorks, Creo, NX, or equivalent)Hands-on experience with NPI, design transfer, and sustaining engineeringStrong experience in root cause analysis (RCA), CAPA, and failure analysis________________________________________
Preferred Qualifications
Experience with Class II / Class III medical devicesFamiliarity with electro-mechanical systems, enclosures, plastics, and precision componentsExperience supporting regulatory submissions (510(k), CE Marking, MDR)Working knowledge of FEA/thermal analysis toolsProven success in driving VAVE/cost savings initiatives ($1M+ impact preferred)Experience working across global manufacturing and supplier ecosystems________________________________________
Key Competencies
Deep understanding of regulated product development lifecycleStrong documentation discipline and attention to detailAbility to operate effectively within a Quality Management System (QMS)Excellent cross-functional collaboration (Quality, Regulatory, Manufacturing, Systems, EE)Structured, >Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
U.S. Work Authorization & Sponsorship
At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD):$106,400.00 - $159,600.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees: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), andCapital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can findherea list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.