Technical Leadership & System Ownership
Act as technical lead for mechanical design within electromechanical medical device programs.
Own the mechanical architecture and interfaces for electro‑mechanical subsystems including enclosures, mechanisms, mounts, thermal paths, cable routing, and EMI/EMC considerations.
Lead end‑to‑end mechanical design activities from concept, feasibility, and prototyping to design freeze and production release.
Translate user needs, system requirements, and electrical/software constraints into robust mechanical designs.
Develop and review 3D CAD models, detailed drawings, GD&T, and BOMs.
Ensure proper integration of motors, sensors, PCBs, batteries, power supplies, connectors, and cabling within mechanical assemblies.
Execute development activities in compliance with ISO 13485, FDA 21 CFR 820, ISO 14971, and applicable IEC standards.
Ensure completeness and quality of Design History File (DHF) documentation.
Lead and participate in risk management activities (dFMEA, pFMEA, hazard analysis) with cross‑functional teams.
Support design changes through formal ECO/ECN processes.
Define mechanical verification strategies and support DVT, EVT, and V&V testing.
Investigate and resolve failures observed during testing, manufacturing, or field feedback.
Lead application of DFM/DFA principles for manufacturing processes.
Work closely with suppliers and contract manufacturers on tooling, materials, processes, and yield improvement.
Support FAI, PPAP, pilot builds, and design transfer to manufacturing.
Drive resolution of manufacturing issues, NCRs, and deviations related to mechanical design.
Collaborate with electronics, software, systems, quality, regulatory, and supply chain teams.
Lead and participate in design reviews, technical discussions, and customer walkthroughs.
Guide and perform engineering analyses including tolerance stack‑ups (hand calculations and FEA).
Provide technical input for cost reduction, design optimization, and next‑generation improvements.
Mentor and technically guide junior and mid‑level engineers.