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. Youll 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:
oDesign inputs/outputs
oVerification & validation plans/reports (DV/PV)
oDesign reviews
oTraceability 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
Bachelors or Masters degree in Mechanical Engineering or related field
46 years of experience in medical device product development or regulated industries
Strong working knowledge of:
oFDA 21 CFR Part 820
oISO 13485 Quality Management Systems
oISO 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 independently under limited supervision to determine and develop approach to and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact:May be responsible for entire projects or processes within job 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 improvements of processes systems or products to enhance performance of the job provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence:Communicates with senior internal and external customers and 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 manage projects requiring delegation of work and review of others work product.

Required Knowledge and Experience: Requires a Baccalaureate degreeand minimum of 4 years of relevant experience OR Masters 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 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 lifewhere 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):$106400.00 - $159600.00

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 insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-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 95000 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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.