SENIOR DIRECTOR OF PRODUCT DEVELOPMENT
The Senior Director will join Thubrikar Aortic Valve, Inc. (the “Company”) immediately in an R&D engineering environment to direct the development of its transcatheter aortic valve and delivery catheter program. The Senior Director will report directly to the President/Founder. This position requires first-hand experience with developing Class 3 medical devices in the US or Europe. The Senior Director will be responsible for navigating regulatory requirements and agencies, developing robust quality management systems, pre-clinical and clinical testing, and hands-on engineering. Candidates should have solid engineering experience and QA/RA knowledge that can be demonstrated with successful products they collaborated on that have been brought to market. Some travel is required (10% of time for international clinical trials, animal studies, physician training, etc.).
- Master’s or PhD in biomedical engineering, mechanical engineering, or a related field
- 6-10 years of experience in a start-up or clinical-stage medical device company
- A demonstrated ability to take a Class 3 medical device from concept through commercial approval
- A demonstrated ability to direct others in multiple areas including engineering, regulatory, quality assurance, risk assessment/analysis, interpreting test results, etc.
- Ability to communicate clearly and effectively with management and other team members
- Flexibility to direct and take direction simultaneously
- Ability to work and think independently, creatively, and effectively to further Company’s objectives
- Thorough knowledge and experience in the application of ISO 13485, ISO 5840, and ISO 10993 standards is preferred
Applicants must be authorized to work in the United States.
Please e-mail job applications with the subject “Senior Director, Product Development” to Info@TAVI.us, or send by postal mail to the address below. No unsolicited visits or phone calls, please. Thank you.
537 Foundry Road, Unit 2C, Norristown, PA 19403