Senior R&D Engineer (Direct Hire)
San Francisco Bay Area, CA
Job Requisition: 6351
Description for Senior R&D Engineer:
As a member of the Manufacturing Engineering group, you will provide expertise and drive results in the engineering, design, development, and implementation of new life-saving products. The ideal candidate will be able to strongly step into the role as a leader in electro-mechanical manufacturing, bringing with them confidence in quality management systems. This individual will be collaborating cross-functionally with Production, R&D, Quality, and other groups.
Responsibilities for Senior R&D Engineer:
- Independently manage day to day project activity for both R&D technical development and cross-functional design control efforts with high level guidance.
- Autonomously design, prototype, and optimize meaningful medical devices that revolutionize treatment paradigms for a variety of challenging disease states.
- Strategize to originate comprehensive documentation packages that contain CAD drawings, product specifications, risk analysis, test protocols, test reports, studies, work instructions, etc adherent to our quality system.
- Coordinate and form lasting relationships with suppliers and other external resources to source components and refine component specifications.
- Collate and distill clinical data from physicians and other medical professionals into comprehensive product specifications to drive superior product performance.
- Develop clinically relevant benchtop models to simulate complex anatomy and disease states.
- Investigate and vet novel technologies and incorporate them into innovative designs.
- Serve as a trustworthy resource who can positively influence and guide junior engineers of varying disciplines through technical and documentation challenges with a focus on their growth.
Requirements for Senior R&D Engineer:
- BS degree in Mechanical, Biomedical, or higher
- Experience working in an R&D environment as a Mechanical Engineer doing 3D/2D design work
- 5+ years of mechanical engineering experience with at least one year of medical device industry experience
- Experience with leadership responsibilities and enjoys mentoring junior members of a team.
- Project management skill set
- Strong interpersonal skills with a positive, up-beat, and self-starter personality (
- Ability to function in a fast-paced environment.
- The ability to communicate complex issues in a clear, compelling manner, both orally and in writing
Desired for Senior R&D Engineer:
- Knowledge of ISO 13485, MDSAP quality standards.
*Legal authorization to work in the U.S. is required. Will not sponsor individuals for employment visas, now or in the future, for this job opening