Sr. Mechanical Engineer -

About the role

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.

Key Responsibilities

• Lead mechanical design activities in compliance with Design Control requirements (21 CFR Part 820 / ISO 13485)
• Develop and maintain design documentation including: Design inputs/outputs, Verification & Validation plans/reports (DV/PV), Design reviews, Traceability matrices (DHF)
• Ensure alignment with User Needs, Intended Use, and Risk Management outputs
• 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)
• 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
• Lead and contribute to risk management activities per ISO 14971 (FMEA, hazard analysis, risk controls)
• Support regulatory submissions (510(k), MDR, etc.) by providing design documentation
• Participate in internal/external audits (FDA, notified bodies) and ensure audit readiness
• 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
• 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: FDA 21 CFR Part 820, ISO 13485 Quality Management Systems, ISO 14971 Risk Management
• Expertise in CAD tools (SolidWorks, Creo, NX, or equivalent)
• Hands-on experience with NPI, design transfer, and sustaining engineering
• Proven experience with design controls and DHF documentation
• 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
• Promised success in driving VAVE/cost savings initiatives ($1M+ impact preferred)
• Experience working across global manufacturing and supplier ecosystems