Sr. Mechanical Engineer

Position: Sr. Mechanical Engineer -
We anticipate the application window for this opening will close on - 21 Aug 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

** 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

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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)

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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

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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

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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

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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

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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 (Solid Works, 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

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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…