Sr. R&D Engineer

Senior R&D Engineer (Direct Hire)

San Francisco Bay AreaCA

Job Requisition:  6413

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
 

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