Mechanical Engineer

Roles & Responsibilities:

• 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.

Requirements:

• 8+ years of experience in mechanical design and development, with significant experience in medical device NPD.


• Proven experience leading mechanical development of electromechanical products through full product lifecycle in regulated environments.


• Bachelor's or Master's degree in Mechanical Engineering.

Required Technical Skills:

• Strong proficiency in CAD tools such as SolidWorks or Creo.


• In‑depth knowledge of materials and manufacturing processes for medical devices.


• Strong understanding of electromechanical integration, thermal considerations, EMI/EMC‑aware mechanical design, and reliability.


• Expertise in GD&T (ASME Y14.5), tolerance stack‑up, and DFM/DFA.


• Knowledge of FEA and practical engineering calculations.