Principal Mechanical Engineer (Console System)

Job Description

Lead the mechanical design and development of complex medical device systems for the Intravascular Lithotripsy platform from concept through commercialization. Collaborate with cross-functional teams to translate clinical requirements into robust mechanical architectures and ensure product reliability and manufacturability.

Requirements: Requires a bachelor's degree in Mechanical Engineering and over 7 years of experience developing complex medical devices or electromechanical systems. Candidates must have expertise in CAD, GD&T, and working within FDA and ISO 13485 regulated environments.

Key Skills: Mechanical Design, GD&T, Tolerance Analysis, SolidWorks, Finite Element Analysis (FEA), Design for Manufacturability (DFM), Design for Assembly (DFA), Design Controls, ISO 13485, Medical Device Development, Risk Management, Verification and Validation, Electromechanical Systems, Root Cause Investigation, Technical Leadership, Regulatory Submissions