San Francisco Bay Area, CA
R&D Engineer – Mechanical
As a Mechanical Engineer, you will work on product development teams to bring complex mechanical designs for implants, surgical devices and external electromechanical devices from concept to market.
- Applies engineering knowledge and skills as technical engineer for all phases of development projects.
- Generate and maintain computer-aided drawings (CAD) using Solidworks, schematics and component specifications to document mechanical designs.
- Participates in hands-on fabrication and testing of prototypes using bench testing, animal and/or cadaver studies to evaluate product designs and recommend and implement design modifications.
- Perform detailed design reviews and tolerance analyses to achieve product performance, cost, reliability, and manufacturability requirements.
- Effectively interface with and manage suppliers to fabricate prototype and final components.
- Develop test plans and protocols and executes prototype testing and design verification testing.
- Creates medical device manufacturing process instructions, bill of materials, lot history travelers, and related documentation.
- Contributes towards coordinating and scheduling other staff to work on specific tasks.
- Communicates directly with clients to understand needs and present results.
- Effectively interfaces with and manages suppliers to fabricate prototype and final design components.
- Participates in product risk management and develops and implements risk mitigation strategies.
- Other duties as assigned.
- Bachelors in Mechanical / Biomedical Engineering, or an equivalent engineering discipline
- Minimum 1-3 years’ experience within the Medical Device industry.
- Experience in development of electromechanical devices (i.e. cable design, wire schematics, integrating PCBAs into mechanical assemblies, etc.) highly preferred.
- Experience with CAD design using SolidWorks.
- Excellent communication skills both written and oral.
- Experience and working knowledge of medical device design control processes highly preferred.