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Job Description
Lead Heart Valve Implant Engineer (en)
A leading structural heart startup is seeking an experienced engineer to develop a breakthrough heart valve replacement.
- Leverage expertise in material development, nitinol, and valve interface requirements to lead detailed design and development of a next-generation aortic valve replacement device.
- Ensure design and development activities meet regulatory requirements per ISO 5840 and clinical end user needs.
- Generate detailed component and subsystem drawings/designs using Solid Works.
- Lead and mentor postdoctoral research candidates in implant development activities, including in silico and in vitro testing.
- Maintain detailed records of design iterations, evaluations, test methods, and analysis.
- Create prototypes and design iterations to evaluate valve designs, materials, and deployment techniques.
- Develop effective bench test methods, including hands-on testing and builds.
- Maintain high standards of documentation throughout project phases to support project requirements and IP/patent disclosures.
- Generate R&D test protocols and technical reports.
- Analyze test data using statistical tools and provide in-depth interpretation of results.
- Support pre-clinical trials and commercial readiness.
- Collaborate with delivery system development partners to optimize deployment of the next-generation valve implant.
- Contribute to cross-functional team risk management activities and implant performance actions.
- Contribute to project planning and regulatory submissions as required.
- Stay up to date with emerging technologies and designs to identify opportunities for innovation and improvement.
Requirements
- Minimum Bachelor of Engineering (Mechanical/Biomedical/Polymer).
- Experience in stent design, polymer processing, and/or heart valves.
- 5+ years of medical device process development/R&D experience.
- Demonstrated proficiency with Solid Works modeling and engineering drawings.
- Familiarity with application of FEA/CFD towards implant development.
- Direct Class III implant design experience.
- Understanding of regulatory requirements, including ISO 5840, ISO 13485, and FDA regulation.
- Demonstrated ability to develop product-driven bench test methods and perform hands-on testing.
- Technical leadership capability to coordinate efforts of graduate engineers, technicians, and FEA engineers.
Additional Information
This is a key role in the development of a breakthrough heart valve replacement, requiring a highly qualified and experienced engineer to lead the design and development activities.