Senior Staff Engineer R&D

New Yesterday

The Opportunity
This position works out of our Santa Clara, CA location in the Ventures division. Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease. We are recruiting for a Senior Staff R&D Engineer to join our Ventures organization in Santa Clara, CA. This is a unique opportunity to join the transcatheter mitral valve replacement program that is developing a first of its kind technology solution for patients suffering from mitral valve disease who could benefit from transfemoral prosthetic mitral valve replacement.
The individual who fills this role will play a pivotal part in the design, development, and testing of this TMVR delivery system from early clinical feasibility through commercialization. The candidate will be responsible for providing engineering expertise in its creation and the development of this class 3 medical device product in this desirable technology space. Hiring Manager - Lior Noyovitch. What You’ll Work On Lead Med Device design and development under Design Controls to ensure compliance and innovation. Oversee Technical System Leadership, including driving decision making processes while considering risk management considerations, time criticality, and business needs. Define Future generations device’s Scope while considering supply chain challenges, emerging user needs and broad technical considerations. Conduct Design of Experiments (DOEs) to optimize product performance, processes and root cause investigations. Perform Risk Analysis to identify and mitigate potential issues. Develop And Evaluate Fabrication Methods to enhance production efficiency. Utilize Simulations to predict and improve system performance and estimate performance boundaries. Execute Root Cause Analysis to resolve technical challenges. Implement Problem-Solving strategies to drive continuous improvement. ​ Required Qualifications Bachelor's degree in mechanical,or equivalent combination of education and work experience. Minimum 10 years in medical device development and/or other highly regulated industry. Expertise using Solidworks. Hands-on experience with trans-catheter heart valve delivery systems. Terrific verbal and written communication skills. Preferred Qualifications Advance degree in a technical field. Extensive knowledge of metals and polymers used in the catheter medical device industry.
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Location:
Santa Clara

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