Sr. Mechanical Engineer -

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 (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 ________________________________________ Preferred Qualifications • 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 ________________________________________ Key Competencies • Deep understanding of regulated product development lifecycle • Strong documentation discipline and attention to detail • Ability to operate effectively within a Quality Management System (QMS) • Excellent cross-functional collaboration (Quality, Regulatory, Manufacturing, Systems, EE) • Structured, data-driven problem solving • Ability to balance compliance, innovation, speed, and cost Responsibilities may include the following and other duties may be assigned. 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. TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. 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. DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product. Required Knowledge and Experience: 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. 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 - $159,600.00 This 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, and Simple 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), and Capital 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 find here a 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. 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. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to te