Senior Principal R&D Engineer Needed for a Class III Medical Device Start Up
- Sonoma County, CA
- Competitive Compensation + Relocation Assistance + High Growth Trajectory
An innovative startup working within the Structural heart and Mitral space is seeking a Senior Principal R&D Engineer. This individual will have a strong track record of creative designs and be a key member of the research and development team. The Senior Principal R&D Engineer will work in team settings but primarily on an independent scale to drive and execute complex and diverse functions to support Research and Development.
If you are seeking a hands-on, technical R&D position within a challenging space - this is the role for you!
RESPONSIBILITIES
- Invents/ creates concepts and designs for new products/processes, and submits idea disclosures.
- Fully leads, participates, and successfully contributes to project teams typically including the following activities: equipment and product design and development, test of materials, preparation of specifications, process capability studies, research investigations (animal and clinical studies), report preparation, and process/test documentation.
- Works independently to plan and schedule own activities necessary to meet timelines.
- Designs/develops and coordinates standard engineering tests and experiments to include validation planning and execution.
- Designs/develops, procures, and fabricates tooling and fixtures.
- Performs troubleshooting on new products/process problems as related to design, material, or process.
- Summarizes, analyzes, and draws conclusions from test results.
- Responsible for preparing and reviewing engineering documentation.
- Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing to develop project plans and strategy and ensure project success.
QUALIFICATIONS
- Minimum 7 years' experience within R&D and Manufacturing of Medical Devices
- Bachelors' Degree in Engineering, Technical or Related Field required, Master's degree or greater strongly preferred
- 4+ years' experience with Cardiovascular catheter/implant design OR structural heart catheter/implant design and development highly desired