{"schemaVersion":"jobsearcher.job.v1","id":"a75136c614efa402c385bd3e","url":"https://jobsearcher.com/jobs/a75136c614efa402c385bd3e","canonicalUrl":"https://jobsearcher.com/jobs/a75136c614efa402c385bd3e","title":"Sr. Mechanical Engineer","description":"We anticipate the application window for this opening will close on 13 Jul 2026.\n\nAt 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.\n\nA Day in the Life\nJob Title: Senior Mechanical Engineer (Medical Devices – Design & Sustaining Engineering)\n\nLocation: [Lafayette, CO / Hybrid / Global]\n\nEmployment Type: Fulltime\n\nPosition Summary\nWe 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.\n\nKey Responsibilities\nDesign & Development (Design Controls)\n\nLead mechanical design activities in compliance with Design Control requirements (21 CFR Part 820 / ISO 13485)\n\nDevelop and maintain design documentation including:\n\nDesign inputs/outputs\n\nVerification & validation plans/reports (DV/PV)\n\nDesign reviews\n\nTraceability matrices (DHF)\n\nEnsure alignment with User Needs, Intended Use, and Risk Management outputs\n\nNew Product Introduction (NPI)\n\nDrive product development from concept through design transfer to manufacturing\n\nSupport prototype builds, design verification (DV), validation (PV), and clinical readiness\n\nCollaborate with manufacturing and quality teams to ensure design for manufacturability (DFM) and scalability\n\nSupport process validation activities (IQ/OQ/PQ)\n\nSustaining Engineering & Post‑Market Support\n\nLead root cause investigations (RCA) for product complaints, CAPAs, and non‑conformances\n\nImplement design changes through controlled Engineering Change Orders (ECOs) with full traceability\n\nSupport post‑market surveillance, field issue resolution, and regulatory reporting inputs\n\nEnsure continuous compliance of released products\n\nRisk Management & Compliance\n\nLead and contribute to risk management activities per ISO 14971 (FMEA, hazard analysis, risk controls)\n\nEnsure design solutions effectively mitigate patient and user risks\n\nSupport regulatory submissions (510(k), MDR, etc.) by providing design documentation\n\nParticipate in internal/external audits (FDA, notified bodies) and ensure audit readiness\n\nCost Optimization & VAVE\n\nDrive Value Engineering / Cost Optimization initiatives while maintaining compliance and product performance\n\nEvaluate alternate materials, components, and manufacturing processes with full regulatory impact assessment\n\nPartner with sourcing and suppliers to implement cost reduction strategies\n\nSupplier & Manufacturing Collaboration\n\nCollaborate with global suppliers to ensure component quality and compliance\n\nSupport supplier qualification and design transfer activities\n\nPartner with manufacturing sites to address design‑related yield, reliability, and quality issues\n\nRequired Qualifications\n\nBachelor’s or Master’s degree in Mechanical Engineering or related field\n\n4–6+ years of experience in medical device product development or regulated industries\n\nStrong working knowledge of:\n\nFDA 21 CFR Part 820\n\nISO 13485 Quality Management Systems\n\nISO 14971 Risk Management\n\nProven experience with design controls and DHF documentation\n\nExpertise in CAD tools (SolidWorks, Creo, NX, or equivalent)\n\nHands‑on experience with NPI, design transfer, and sustaining engineering\n\nStrong experience in root cause analysis (RCA), CAPA, and failure analysis\n\nPreferred Qualifications\n\nExperience with Class II / Class III medical devices\n\nFamiliarity with electro‑mechanical systems, enclosures, plastics, and precision components\n\nExperience supporting regulatory submissions (510(k), CE Marking, MDR)\n\nWorking knowledge of FEA/thermal analysis tools\n\nProven success in driving VAVE/cost savings initiatives (≥ $1M impact preferred)\n\nExperience working across global manufacturing and supplier ecosystems\n\nKey Competencies\n\nDeep understanding of regulated product development lifecycle\n\nStrong documentation discipline and attention to detail\n\nAbility to operate effectively within a Quality Management System (QMS)\n\nExcellent cross‑functional collaboration (Quality, Regulatory, Manufacturing, Systems, EE)\n\nStructured, data‑driven problem solving\n\nAbility to balance compliance, innovation, speed, and cost\n\nResponsibilities may include the following and other duties may be assigned.\n\nResearches, 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.\n\nRecommends various technology options or approaches for system, processes, facility or program improvements in terms of safety, performance, efficiency or costs.\n\nMay be responsible for the transfer from R&D to manufacturing.\n\nTECHNICAL SPECIALIST CAREER STREAM\nAn 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.\n\nDIFFERENTIATING FACTORS\nAutonomy: 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.\n\nOrganizational 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.\n\nInnovation 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.\n\nCommunication and Influence: Communicates with senior internal and external customers and vendors. Exchanges information of facts, statuses, ideas and issues to achieve objective, and influence decision‑making.\n\nLeadership 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.\n\nRequired 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.\n\nFor 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.\n\nPhysical Job Requirements\nThe 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.\n\nU.S. Work Authorization & Sponsorship\nAt 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.\n\nBenefits & Compensation\nMedtronic offers a competitive salary and flexible benefits package. A commitment to our employees' lives 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.\n\nSalary ranges for U.S. (excluding 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).\n\nHealth, Dental and vision insurance\n\nHealth Savings Account\n\nHealthcare Flexible Spending Account\n\nLife insurance, Long‑term disability leave\n\nDependent daycare spending account\n\nTuition assistance/reimbursement\n\nSimple Steps (global well‑being program)\n\nBenefits and additional compensation are available to all regular employees, including:\n\nIncentive plans, 401(k) plan plus employer contribution and match\n\nShort‑term disability\n\nPaid time off\n\nPaid holidays\n\nEmployee Stock Purchase Plan\n\nEmployee Assistance Program\n\nNon‑qualified Retirement Plan Supplement (subject to IRS earning minimums)\n\nCapital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)\n\nRegular 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. Some benefits may not apply to workers in Puerto Rico.\n\nMedtronic benefits and compensation plans are available at the link below.\n\nAbout Medtronic\nWe 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.\n\nLearn more about our business, mission, and our commitment to diversity here.\n\nIt 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.\n\n#J-18808-Ljbffr","company":"Cobioscience","rawCompany":"cobioscience","city":"Lafayette","state":"CO","isRemote":false,"isActive":false,"createdAt":"2026-06-20T03:18:37.109Z","occupations":[{"code":"17-2141.00","title":"Mechanical Engineers","slug":"mechanical-engineers"},{"code":"17-2031.00","title":"Bioengineers and Biomedical Engineers","slug":"bioengineers-and-biomedical-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Sr. Mechanical Engineer","description":"We anticipate the application window for this opening will close on 13 Jul 2026.\n\nAt 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.\n\nA Day in the Life\nJob Title: Senior Mechanical Engineer (Medical Devices – Design & Sustaining Engineering)\n\nLocation: [Lafayette, CO / Hybrid / Global]\n\nEmployment Type: Fulltime\n\nPosition Summary\nWe 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.\n\nKey Responsibilities\nDesign & Development (Design Controls)\n\nLead mechanical design activities in compliance with Design Control requirements (21 CFR Part 820 / ISO 13485)\n\nDevelop and maintain design documentation including:\n\nDesign inputs/outputs\n\nVerification & validation plans/reports (DV/PV)\n\nDesign reviews\n\nTraceability matrices (DHF)\n\nEnsure alignment with User Needs, Intended Use, and Risk Management outputs\n\nNew Product Introduction (NPI)\n\nDrive product development from concept through design transfer to manufacturing\n\nSupport prototype builds, design verification (DV), validation (PV), and clinical readiness\n\nCollaborate with manufacturing and quality teams to ensure design for manufacturability (DFM) and scalability\n\nSupport process validation activities (IQ/OQ/PQ)\n\nSustaining Engineering & Post‑Market Support\n\nLead root cause investigations (RCA) for product complaints, CAPAs, and non‑conformances\n\nImplement design changes through controlled Engineering Change Orders (ECOs) with full traceability\n\nSupport post‑market surveillance, field issue resolution, and regulatory reporting inputs\n\nEnsure continuous compliance of released products\n\nRisk Management & Compliance\n\nLead and contribute to risk management activities per ISO 14971 (FMEA, hazard analysis, risk controls)\n\nEnsure design solutions effectively mitigate patient and user risks\n\nSupport regulatory submissions (510(k), MDR, etc.) by providing design documentation\n\nParticipate in internal/external audits (FDA, notified bodies) and ensure audit readiness\n\nCost Optimization & VAVE\n\nDrive Value Engineering / Cost Optimization initiatives while maintaining compliance and product performance\n\nEvaluate alternate materials, components, and manufacturing processes with full regulatory impact assessment\n\nPartner with sourcing and suppliers to implement cost reduction strategies\n\nSupplier & Manufacturing Collaboration\n\nCollaborate with global suppliers to ensure component quality and compliance\n\nSupport supplier qualification and design transfer activities\n\nPartner with manufacturing sites to address design‑related yield, reliability, and quality issues\n\nRequired Qualifications\n\nBachelor’s or Master’s degree in Mechanical Engineering or related field\n\n4–6+ years of experience in medical device product development or regulated industries\n\nStrong working knowledge of:\n\nFDA 21 CFR Part 820\n\nISO 13485 Quality Management Systems\n\nISO 14971 Risk Management\n\nProven experience with design controls and DHF documentation\n\nExpertise in CAD tools (SolidWorks, Creo, NX, or equivalent)\n\nHands‑on experience with NPI, design transfer, and sustaining engineering\n\nStrong experience in root cause analysis (RCA), CAPA, and failure analysis\n\nPreferred Qualifications\n\nExperience with Class II / Class III medical devices\n\nFamiliarity with electro‑mechanical systems, enclosures, plastics, and precision components\n\nExperience supporting regulatory submissions (510(k), CE Marking, MDR)\n\nWorking knowledge of FEA/thermal analysis tools\n\nProven success in driving VAVE/cost savings initiatives (≥ $1M impact preferred)\n\nExperience working across global manufacturing and supplier ecosystems\n\nKey Competencies\n\nDeep understanding of regulated product development lifecycle\n\nStrong documentation discipline and attention to detail\n\nAbility to operate effectively within a Quality Management System (QMS)\n\nExcellent cross‑functional collaboration (Quality, Regulatory, Manufacturing, Systems, EE)\n\nStructured, data‑driven problem solving\n\nAbility to balance compliance, innovation, speed, and cost\n\nResponsibilities may include the following and other duties may be assigned.\n\nResearches, 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.\n\nRecommends various technology options or approaches for system, processes, facility or program improvements in terms of safety, performance, efficiency or costs.\n\nMay be responsible for the transfer from R&D to manufacturing.\n\nTECHNICAL SPECIALIST CAREER STREAM\nAn 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.\n\nDIFFERENTIATING FACTORS\nAutonomy: 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.\n\nOrganizational 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.\n\nInnovation 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.\n\nCommunication and Influence: Communicates with senior internal and external customers and vendors. Exchanges information of facts, statuses, ideas and issues to achieve objective, and influence decision‑making.\n\nLeadership 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.\n\nRequired 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.\n\nFor 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.\n\nPhysical Job Requirements\nThe 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.\n\nU.S. Work Authorization & Sponsorship\nAt 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.\n\nBenefits & Compensation\nMedtronic offers a competitive salary and flexible benefits package. A commitment to our employees' lives 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.\n\nSalary ranges for U.S. (excluding 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).\n\nHealth, Dental and vision insurance\n\nHealth Savings Account\n\nHealthcare Flexible Spending Account\n\nLife insurance, Long‑term disability leave\n\nDependent daycare spending account\n\nTuition assistance/reimbursement\n\nSimple Steps (global well‑being program)\n\nBenefits and additional compensation are available to all regular employees, including:\n\nIncentive plans, 401(k) plan plus employer contribution and match\n\nShort‑term disability\n\nPaid time off\n\nPaid holidays\n\nEmployee Stock Purchase Plan\n\nEmployee Assistance Program\n\nNon‑qualified Retirement Plan Supplement (subject to IRS earning minimums)\n\nCapital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)\n\nRegular 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. Some benefits may not apply to workers in Puerto Rico.\n\nMedtronic benefits and compensation plans are available at the link below.\n\nAbout Medtronic\nWe 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.\n\nLearn more about our business, mission, and our commitment to diversity here.\n\nIt 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.\n\n#J-18808-Ljbffr","datePosted":"2026-06-20T03:18:37.109Z","dateModified":"2026-06-20T03:18:37.109Z","hiringOrganization":{"@type":"Organization","name":"Cobioscience","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Lafayette","addressRegion":"CO","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"a75136c614efa402c385bd3e"},"url":"https://jobsearcher.com/jobs/a75136c614efa402c385bd3e"}}