San Francisco Bay Area, CA
Senior R&D Mechanical Engineer
The Senior / Principal Mechanical Engineer will be responsible for design and development of mechanical and electromechanical medical devices.
- Applies engineering knowledge and skills as technical engineer for all phases of development projects.
- Participates in and often leads efforts to create product specifications and develop novel designs to meet those specifications.
- Participates in hands-on development, fabrication and testing of device prototypes.
- Generates and executes test protocols to verify functionality and generates test reports.
- Generates and maintains appropriate design and manufacturing process documentation for Design History File (DHF).
- Often coordinates and manages other technical staff to work on specific tasks.
- Communicates directly with clients to understand project needs and present results.
- Effectively interfaces with and manages suppliers to fabricate prototypes and components.
- Participates in risk management activities, and develops and implements risk mitigation strategies.
- Minimum BSE/BSME with 10-20 years of experience within the Medical Device industry.
- Extensive experience with design and development of mechanical and electro-mechanical devices, preferably class III devices.
- Significant experience as a technical team leader.
- Experience with project management preferred.
- Must be proficient with Solidworks.
- Experience in creating and managing product requirements, writing verification test protocols and test reports, and generating manufacturing procedures.
- Experience with design for manufacturing and assembly.
- Excellent communication skills, both written and oral.
- Deep knowledge of medical device design control processes.