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Principal stent engineer r&d transcatheter heart valve

Foldax Inc.

This is a Full-time position in Lake Forest, CA posted July 8, 2019.

Foldax is an early stage company developing a complete line of surgical and catheter-delivered (TAVR/TMVR) synthetic heart valve products.

We are looking for the ideal candidate to join our team.

This position will be on a fast-paced, early product development team and the individual who fills it will play a key role in the design, development and testing of valve designs from concept to early clinical feasibility.Job :
· Apply engineering principals to the design and development of implant designs.
· Design and develop complex interventional implants, including developing design requirements, prototype builds, pre-clinical evaluations and support of pre-clinical and clinical studies.
· Work closely with physician and scientific partners in both pre-clinical and clinical settings.

Maintain a strong knowledge and understanding of cardiovascular anatomy, structures of the heart, and valve diseases.
· Work closely with Manufacturing, Clinical Affairs, Quality, Marketing, outside consultants, and vendors/suppliers, while following internal and external policies and procedures.Required Work Experience and Education :
· A bachelor’s degree in engineering, mechanical or biomedical preferred.

· Experience in Nitinol stent design is required.
· Must have 4+ years experience in transcatheter heart valves and 8+ years in the medical device industry.

· Creative design experience using Solidworks, ProE, or other engineering design software.
· Hands-on experience with implant design, prototyping, and testing.
· Must have a strong knowledge of structural heart valve requirements, test equipment, and test methods in accordance with specifications, medical guidance and regulatory safety standards.
· Successful design experience from concept to commercialization strongly preferred.Skills :
· Creative thinking and problem-solving skills.
· Maintain documentation of concepts, designs, drawings, and processes.
· Understanding of material properties (polymers, adhesives, stainless steel, nitinol).
· Effective communication, verbal and written, are necessary.
· Ability to work well independently and as a member of a team.
· Must be a proactive self-starter.
· Comfortable interacting with interventional cardiologists and cardiac surgeons as well as taking the lead role on design projects.Benefits : This is a full time salaried position, is eligible for stock options and includes an employer sponsored healthcare plan and paid time off.