Mechanical Engineer

Job Description

Act as the technical lead for mechanical design in electromechanical medical device programs, overseeing the full 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 be proficient in CAD tools like SolidWorks or Creo and have deep expertise in GD&T and regulated manufacturing standards.

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 Development, Prototyping, BOM Management