Sr Mechanical Design Engineer

4 weeks ago


Irvine, United States People With Chemistry Full time

A growing medical device design and manufacturer based in Orange County, CA is expanding their R&D team to initiate new product development projects for Orthopedic, Neuro, Spine, and Dental Surgery. The Engineering Manager is seeking an experienced Mechanical Design Engineer to act as an R&D technical lead for development of electrosurgical instruments. This role will require prior industry experience designing and developing small, electromechanical surgical devices. Responsibilities: Design, develop, and evaluate mechanical and electro-mechanical systems, components, machined parts, processes and equipment. Develop, verify, validate requirements/specifications of medical device products. Design and conduct experiments in the lab to aid in design development and test method development. Perform statically driven data analysis. Conduct feasibility studies to verify capability and functionality of components, subassemblies and completed medical devices. Work with manufacturing to support process development and release of new products into production. Maintain detailed documentation throughout all phases of research and development. Requirements: A bachelor's degree in Mechanical Engineering or related field. 5-8 years of R&D engineering experience in the medical device industry; knowledge of IEC 60601-x, ISO 13485. 4+ years of experience developing electrosurgical devices and powered surgical instruments. Hands-on design and development experience of small electromechanical systems/devices. Experience with CNC Machine part design, GD&T, tolerance stack-up analysis, and stress analysis. Experience with 3D Solid Modeling CAD software - SolidWorks preferred.



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