Significant opportunity for an experienced and successful manager of medical device product development, including single use devices. You would report to the VP of R&D and join an expanding developer of innovative systems for treating cardiac arrhythmias. The company’s devices have cured thousands of patients with this life threatening condition.
The role requires a self-starter who will take ownership for assembling and developing project teams, developing product specifications, and leading R&D teams through all the stages of the design, development, and scale-up process for new devices and enhancements for intricate, multi-lumen catheters. Responsibilities include ideation and invention, solving unique technical challenges, management of Design History Files, creation of new production methods, and support of regulatory submissions. This broad and challenging role requires strong analytical and problem solving skills, the ability to manage teams in the generation of creative design solutions. The Director/ Senior Manager of Medical Device Research and Development will work closely with senior managers across all the company’s functional groups.
- BS or MS in Engineering and 10 plus years of successful R&D experience in the medical device industry, including project and people leadership roles.
- Demonstrated ability to lead medical device projects from concept through commercialization.
- Experience developing complex catheters for cardiology or neurology is strongly desired.
- Exposure and contribution to the development of catheter delivered imaging devices is a plus.
- Excellent project management, planning and organization skills are required; PMP training is plus.
- Working knowledge of regulatory requirements for Class III device development.
- Strong oral and written communications skills.