R&D Project Engineer (Implantable Medical Device)
The Bridgeway Group (Irvine, California)
Posted: January 31, 2013
Address: Irvine, CA 92618
Type: Full-time
Job Description
This position is responsible for the research, design, and development of endovascular access, delivery systems and implantable medical devices for the treatment of peripheral and neurovasculature diseases.
Major Responsibilities:
- Establishing product customer requirements, concept prototyping, conducting and overseeing product design and development (including verification and validation), material selection, risk/failure mode assessment, performance and safety.
- Development and validation of test methodology
- Physician Interface
- Performing pre-clinical in-vitro and in-vivo testing
- Directly supervising one or more associate engineers and/or technicians
- Documenting of all project outputs
- Complying with applicable FDA / ISO13485 requirements
- Assisting with pilot-production and post-production GMP compliance
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