Performs research and development activities including design concept development and
evaluation, engineering analysis, engineering prototyping, materials and component selection,
and development of specifications and other documentation. Works closely with the design group
in translating engineering designs into hardware and supports the transfer of prototype
fabrication to manufacturing. Implements test programs and writes reports for regulatory
submissions. Assists in basic research studies, including animal and clinical investigations.
Contributes to other engineering activities effecting current and future products, including
failure investigation, trouble shooting, and reverse engineering. Performs other duties as
required by supervisor.
Must have excellent written and verbal communication skills and be able to work closely with
project team members from Regulatory, Quality, Manufacturing, and other departments. Must also
be able to work closely with outside vendors. Must be able to write clear technical
descriptions of rationales, designs, observations, conclusions, and implementation
instructions. Must also be able to prepare documents for design specification, verification
and validation, and technical review. Familiarity with other documentation development, e.g.
risk analysis, manufacturing processes, etc., is desirable.
EDUCATION and EXPERIENCE:
Requires a B.S. in Engineering; M.S. or Ph.D. is a plus. Requires eight to twelve years
experience, with four years in product development of medical devices, preferably
cardiovascular. Experience in or familiarity with a range of technical activities is desirable
including biomaterials, biomechanics, medical engineering, project management, and regulatory
requirements such as ISO, GMP, FDA, and CE. Should have experience with solid modeling
software (SolidWorks); experience with analysis tools for FEA, CFD, and others is a plus.
No relocation assistance is available with this position.
Thoratec offers an excellent benefits package with opportunities for advancement. Email your
resume and salary requirement to HRJobsCA2@thoratec.com