Business Title Mechanical Engineer II
Core
Design and develop innovative medical devices or components/subsystems for cardiac rhythm management, ensuring compliance with FDA and ISO regulations.
Role type
Mechanical Engineer II (Product Development)
Builds
Medical device sub-assemblies and components for CRM Cardiac Rhythm Management
Domain
Healthcare / Medical Devices / Cardiac Rhythm Management
Required skills
Mechanical engineering, CAD (Solidworks/Creo), FEA, Design for Six Sigma, Risk management, Regulatory compliance (FDA/ISO), Prototype development, Test method development
Preferred skills
Biomedical engineering, Manufacturing processes, DFM, Clinical environment understanding, Cross-functional collaboration
Technologies
Solidworks, Creo, FEA tools
Responsibilities
Design sub-assemblies to meet broad design goals, analyze designs using empirical/numerical/experimental methods, mitigate sub-assembly risks, support pre-clinical and clinical testing, prepare risk management files, drive design quality and reliability, manage project schedules within regulatory requirements.
Seniority
Mid-level Individual Contributor