Location: Sunnyvale, CA
The Sr R&D Engineer is responsible for the design and development of new & improved products and procedures to address vascular diseases and conditions using minimally invasive techniques.
Major Duties & Responsibilities:
· Design, prototype and develop novel catheter design solutions to improve performance and ease of use in clinical procedures.
· Work collaboratively with Marketing, Clinical, CMO and physician advisors to understand customer requirements. Develop deep understanding of procedural constrains, needs, and customer expertise to better inform this understanding.
· Establish and maintain partnerships with OEM suppliers, development partners, and other vendors as projects require.
· Maintain Design Control activities for new product development from initial concept through commercialization. These activities may include the following: developing product specifications, performing robust design evaluation, creating risk analyses, meeting goals for design reviews, and setting & executing design verification and validation strategies.
· Develop and lead verification and validation activities to ensure that product designs meet the customer needs. This shall include bench testing, model/fixture development, ex vivo and/or in vivo testing as appropriate.
· Performs troubleshooting on new catheter products/process problems as related to design, material, or process.
· Work collaboratively with other company functions as needed, including R&D, Marketing, Operations, Quality, Clinical and Regulatory to ensure project success.
· Support the development and upkeep of the Company’s quality system in conjunction with the Company’s Quality Department.
· May assist with Clinical Training activities (design and development of training tools and models, direct interface with field personnel and customers).
· Design and develop test methods and associated test fixtures to be used in the test and evaluation of new products.
· BS in Biomedical Engineering, Mechanical Engineering, or a related discipline
· MS in Biomedical Engineering, Mechanical Engineering, or a related discipline a plus.
· Minimum of 6 years of experience in industry, 4 of which are in medical device R&D. Previous experience with catheter design and manufacturing (i.e. coil winding, braiders, etc) is a plus.
· Highly organized, energetic, self-starter who exhibits strong communication skills with cross-function team members, project leads, & physician advisors.
· Excellent hands-on design and prototyping skills.
· Extensive product and process development experience particularly with catheter design and manufacturing.
· Project management experience and strong report writing, drafting and documentation skills.
· Proficient with the following: 3D Modeling (Solidworks), FEA desirable (not required.) Microsoft Office Suite.
· Strong understanding of FDA Regulation and Quality systems requirements for Medical Device Manufacturers
· Be willing to travel up to 20%
We are a public company that develops and manufactures less-invasive medical devices intended to improve the treatment of carotid artery disease through proprietary transcarotid therapies. By innovating around proven surgical principles and developing breakthrough technology for vascular specialists, we can improve the lives of people with carotid artery disease. Our history is one of deep collaboration with vascular specialists and our future will be guided by continuous learning, observation, and improvement.