Edwards Lifesciences Corp Irvine , CA 92606
Exceptional opportunity for an experienced engineer to join a highly talented and diverse R&D team working on the next-generation medical devices in the cardiovascular area.
Testing of class III implantable medical devices in accordance with the specifications, medical guidance and regulatory safety standards.
Provide engineering expertise to the R&D team in the design and development of next-generation implantable heart valves and components.
Support and execute implant-testing operations (accelerated wear testing and hydrodynamic testing) as a member of product development team.
Solve mechanical engineering problems at the component through system level, and incorporate fairly complex technical analyses in the overall design and development process.
Select materials, develop test methods, gather and analyze fatigue and durability data for implantable devices.
Conduct accelerated wear testing and hydrodynamic testing by utilizing existing test protocols, or develop new ones as needed.
Maintain documentation of concepts, designs, drawings, and processes. Research competitive technologies in addition to medical, technical, and biomedical developments related to company products, and generate written reports.
Supervise and mentor junior level technical staff, including engineers.
Interface with manufacturing, clinical affairs, quality, sales and marketing, outside consultants and vendors to ensure compliance with internal and external policies and procedures, Quality System Regulations, and FDA/ISO regulations.
A bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science and Engineering or related discipline is required. Advanced degree is certainly a plus.
8 years of relevant product development and/or testing experience in class III medical devices.
Experience in the medical implants product development, characterization and design verification/validation testing (specifically, heart valves or related products) is preferred.
Understanding of/Proficiency in the various hemodynamics characterization and assessment methods such as computational fluid dynamics and particle image velocimetry is desired.
Must be a highly motivated self-starter and able to achieve the high-quality results with minimal direction.
Must be proactive and creative in solving technical problems with limited amount of data/information.
Requires a high-energy individual with excellent team-player attitude and well developed negotiation skills.
Excellent verbal and written communication skills, project-management skills, detail orientation and analytical/problem-solving skills are a must.
Knowledge and experience of relevant FDA guidance and ISO standards such as ISO5840 would be ideal.