R-D Engineer II
- Contribute to the development of design solutions that address broad development problems involving heart valves, aortic stent grafts, and accessories.
- Develop advanced new test methods, measurement techniques, and fixtures.
- Organize, prepare, and present technical information material in a clear, effective and skillful manner to management, marketing, clinicians, and regulators.
- Generate and document invention disclosures to secure intellectual property on therapies, procedures, and associated devices.
- Direct the activities of junior employees and technicians to ensure project milestones are completed correctly and on schedule.
- Coach and mentor junior employees, interns, and co-op students.
- Analyze test results using statistical distribution and regression analyses, using software tools such as Minitab, JMP, or MATLAB.
- Perform fractographic or failure mode analysis on Nitinol heart valves and accessories using optical microscopy, scanning electron microscopy (SEM), energy-dispersive X-ray spectroscopy (EDS), and other techniques as needed.
- Identify the root causes of failures and propose design or process improvements to enhance performance and reliability.
- Maintain technical knowledge current with advancing technology related to cardiovascular valve repair/replacement products and associated accessories.
- Proactively manage deliverables on a geographically diverse, cross-functional team and provide regular updates to both project and functional management.
- Be responsive to changes in work direction and develop creative plans for meeting aggressive business milestones.
- Degree in Mechanical Engineering or Material Science.
- Knowledge of Nitinol design, processing, and material property testing, including fatigue.
- Hands on experience with TA Instruments and/or Instron electromechanical fatigue test frames.
- Experience with aortic stent graft or heart valve development and manufacturing.
- Proficiency with CAD software such as SolidWorks.
- Familiarity of FEA software and design optimization techniques.
- Knowledge of FDA and MDR regulations.
Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
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