The position requires collaboration with physicians, coworkers in R&D, and contractors. Requires a working knowledge of Regulatory, Quality Systems, and Manufacturing to assist in development of new products. Interaction with domestic component suppliers and contract manufacturers is expected. The R&D Engineer position is responsible for developing, testing and improving new medical device concepts and devices. Requires the ability to dive into medical literature and procedures to develop a deep understanding of the state of medical practice, competition, standard-of-care, outcomes, and basic medico-economics.
Responsible for working with other members of engineering team and vendors to design, prototype, develop, test and troubleshoot medical device and mechanical assemblies in accordance with established policies, goals and objectives.
- A minimum of two years of creative design expertise using ProE or Solidworks.
- Must be able to demonstrate strong skills as an innovator and problem solver. Hands-on experience with catheter design and implants.
- Requires the proven ability to apply technical knowledge and judgment to complex technical problems and technical proficiency specific to mechanical problem solving in medical device design.
- Prepare appropriate design documentation in accordance with quality system requirements.
- Plans the fabrication of prototype components and systems, in conjunction with the development of methods and procedures for testing products or systems.
- Support inhouse and outsourced production to ensure that quality
- Other activities as required to support company objectives.
PROFESSIONAL EXPERIENCE / QUALIFICATIONS