Sr. Mechanical Engineer

## Sr. Mechanical Engineer -Applyremote type: Onsitelocations: Lafayette, Colorado, United States of Americatime type: Full timeposted on: Posted Todaytime left to apply: End Date: July 13, 2026 (27 days left to apply)job requisition id: R69256We anticipate the application window for this opening will close on - 13 Jul 2026At 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. #J-18808-Ljbffr