US-CA-Mountain View: Structural Heart Group Test Engineer
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Date: 22-Jul-2008
Structural Heart Group Test Engineer
SUMMARY:
The Structural Heart Group Test Engineer will be the key engineer
responsible to conduct various testing required by the FDA and EC for
approval of Structural Heart Group products. Qualified candidates will
possess basic working knowledge of fluid dynamics, accelerated testing
of implantable cardiovascular devices, corrosion testing of
implantable materials, material property testing and component fatigue
testing. Test Engineer may also participate in preclinical testing of
devices. Qualified candidates will need to have strong work ethics,
possess strong ability to prepare SOPs and test reports and be
identified within the group as the expert in test modalities. Engineer
will need to be able to design, construct and maintain test fixtures.
RESPONSIBILITIES:
* Key engineer for preparing and executing test protocols and
authoring reports consistent with the need and requirements of ASTM,
FDA, EN and other guidance standards for testing of cardiovascular
implants and catheter based delivery systems. * Participate in team
environment and support overall team effort to achieve aggressive
milestones and deliverables. * Apply technical knowledge to innovate,
design (via CAD or SolidWorks) and develop test fixtures, test systems
and provide excellence in test reporting and presentations. * Provide
constructive and timely feedback to design engineers with respect to
early detection of potential failure modes * Establish understanding
of product design and manufacturing to participate effectively in
relaying back potential failure issues * Participate in team
discussions and brainstorming to resolve potential design issues *
Strong attention to detail in reports and documents. * Investigate
quality issues for root cause and recommend/implement/document
corrective actions. * Other duties as assigned.
QUALIFICATIONS:
* Bachelor’s degree in Engineering or Life Science is required. A
degree in Mechanical, Materials, or Biomedical Engineering preferred.
* 4+ years of experience in a medical device company with demonstrated
previous responsibility for device testing. * Excellent technical
writing skills * Self starter and able to conduct assignments with
limited support staffing * Working knowledge of FDA QSR / ISO 9000/ EN
regulatory requirements * Must be challenged by a team-based
environment which places high degree of emphasis on accountability for
quality and completeness of work * Prior experience with image capture
and archive systems preferred
Thank you,
BioTech FYI Center
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