Sr Mechanical Design Engineer

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.