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 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 DFM/DFA principles.

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