Engineering Manager, Transcatheter Heart Valve (Thv) Testing

Edwards Lifesciences Corp Irvine , CA 92606

Posted 2 months ago

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.

Responsibilities include:

  • 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.

#LI-LM2

#MI

Requirements:

  • 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.

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Engineering Manager, Transcatheter Heart Valve (Thv) Testing

Edwards Lifesciences Corp