- Job Type: Full-Time
- Function: Engineering Prod Mgmt/Dev
- Industry: Life Science
- Post Date: 10/14/2021
- Website: www.innovheart.com
- Company Address: 55 Chapel St, Ste 010, Newton, MA, 02458
About InnovheartInnovHeart s.r.l., with locations in Milan, Italy and Poway, Calif, develops transcatheter mitral valve replacement (TMVR) systems to treat patients suffering from mitral valve disease. The Company is in late preclinical development of its novel TMVR Saturn Prosthesis, designed to be consistent with the anatomy of the mitral valve and, currently, in development as a Transapical as well as a Transeptal system. InnovHeart is backed by leading investor Genextra S.p.A, Italian based holding company specialized in early-stage investments in the life sciences sector.
We are looking for a Product Development Engineer, who will support R&D efforts as directed by the Sr. Director for a Trans-Septal Mitral Valve Delivery System.
Tasks include assisting with preparation of the dFMEA, DIR, Design Verification test methods, and establishment of risk-based objective criteria for challenging the test devices in Design Verification and Design Validation. Additionally, the Product Development Engineer will assist with mechanical design, development, and detailing of catheter-based solutions to support refinement of the delivery system through working with partners for prototyping and testing activities. In short, this role can be viewed as primarily a design engineering with quality engineering experience, focusing on risk-based specification development and documentation as well as basic mechanical design and development support.
The ideal candidate will have 5+ years of related cardiovascular catheter engineering experience, although general medical device experience will be considered.
- Engineering or related biomedical degree
- 5+ years of medical device development experience (cardiovascular experience preferred)
- Experience developing dFMEAs, DIRs, Test Methods and Test Method Validations
- Ability to work in a start-up environment (self-starter, motivated, hands-on, small team collaboration)