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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

Please submit your information to: recruiting@hansenmedical.com

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