Senior Mechanical Design Engineer – Medical Devices

Job Description

We are looking for a Senior Mechanical Design Engineer to lead mechanical design and development for electromechanical medical device programs. The role will own mechanical architecture, interfaces, design development, verification, validation, and production release across the full product lifecycle. The engineer will work closely with Electronics, Software, Systems, Quality, Regulatory, Manufacturing, Suppliers, and Contract Manufacturers in a regulated medical-device environment. The position requires strong experience in medical-device NPD, electromechanical integration, mechanical analysis, design controls, and design transfer.

Key Skills

• Technical leadership in mechanical design, mechanical architecture, and electromechanical integration for medical devices, including enclosures, mechanisms, mounts, thermal paths, cable routing, motors, sensors, PCBs, batteries, power supplies, and connectors.
• SolidWorks or Creo, 3D CAD modeling, detailed drawings, BOMs, GD\&T per ASME Y14\.5, tolerance stack-ups, FEA, and engineering calculations.
• Medical-device materials and manufacturing processes, DFM/DFA, reliability engineering, thermal considerations, EMI/EMC-aware mechanical design, tooling, supplier coordination, and contract manufacturing.
• Medical-device product development from concept, feasibility, prototyping, EVT/DVT, verification and validation through design freeze, production release, and design transfer.

Required Qualifications

• Bachelor’s or Master’s degree in Mechanical Engineering.
• 8–12 years of Mechanical Design and Development experience with significant Medical Device NPD experience.
• Proven experience leading electromechanical product development through the full product lifecycle in regulated environments.
• Experience with ISO 13485, FDA 21 CFR 820, ISO 14971, FMEA, hazard analysis, Design History File documentation, and applicable IEC standards.
• Hands-on experience with DFM/DFA, FEA, engineering calculations, tolerance stack-ups, GD\&T, ASME Y14\.5, EVT/DVT, V\&V, ECO/ECN, production release, and design transfer.

Additional Skills

• Windchill or Agile PLM/QMS, EMI/EMC-aware mechanical design, thermal management, and reliability engineering.
• Supplier and contract manufacturer management, tooling, materials, manufacturing processes, FAI, PPAP, pilot builds, NCRs, deviations, and yield improvement.
• Experience integrating motors, sensors, PCBs, batteries, power supplies, connectors, and cabling within mechanical assemblies.
• Strong cross-functional leadership, design reviews, customer walkthroughs, cost reduction, design optimization, next-generation improvements, and mentoring of junior and mid-level engineers.