Mechanical Engineer

Job Description

Act as the technical lead for mechanical design of electromechanical medical devices, overseeing the full lifecycle from concept to production. Responsible for mechanical architecture, risk management, and ensuring compliance with medical device regulatory standards.

Requirements: Requires a Bachelor's or Master's degree in Mechanical Engineering and over 8 years of experience in medical device new product development. Must be proficient in CAD tools like SolidWorks or Creo and expert in GD&T and manufacturing processes.

Key Skills: Mechanical Design, Electromechanical Integration, SolidWorks, Creo, GD&T, DFM/DFA, FEA, ISO 13485, FDA 21 CFR 820, ISO 14971, Risk Management, Tolerance Stackup, Design History File, Medical Device NPD, Thermal Management, EMI/EMC Design