Mechanical Engineer

Job Description

Act as the technical lead for mechanical design of electromechanical medical devices, overseeing the full product lifecycle from concept to production. Responsibilities include owning mechanical architecture, ensuring regulatory compliance, and collaborating with cross-functional teams for manufacturing transfer.

Requirements: Requires a Bachelor's or Master's degree in Mechanical Engineering and over 8 years of experience in medical device new product development. Candidates must demonstrate proficiency in CAD tools like SolidWorks or Creo and expertise in GD&T and regulated manufacturing standards.

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