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Details
Principal Heart Valves Engineer
Reference: | JCAO0401 | Location: |
Galway |
Qualification: | Degree | Experience: | 7-9 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
Principal Engineer, Senior Research and Development Engineer
Principal Heart Valves Engineer
Our client a structural heart startup based in Galway, Ireland are seeking a lead heart valve implant engineer to join their team to work on the development of a breakthrough heart valve replacement. Reporting to the CTO, this position will lead detailed design and development of a next-generation aortic valve replacement device from concept and pre-clinical trial evaluation through to clinical studies.
Role/Responsibilities:
- Leverage an in-depth understanding of material development, nitinol, and valve interface requirements and test methodologies.
- Ensure all design and development activities meet required regulatory requirements per ISO 5840 and clinical end user requirements.
- Generate detailed component and subsystem drawings/designs using SolidWorks.
- Lead and mentor postdoctoral research candidates engaged in implant development activities at our academic partner institution including in silico and in vitro testing: FEA,CFD, FSI, hemodynamic performance analysis, etc.
- Maintain detailed records of design iterations, evaluations, test methods, and analysis.
- Create prototypes and design iterations and conduct feasibility studies to evaluate valve designs, materials, and impact on deployment techniques.
- Develop effective bench test methods including conducting hands-on testing and builds.
- Maintain high standard of documentation of work during all project phases to support overall project requirements/deliverables and IP/patent disclosures.
- Generate R&D test protocols & technical reports.
- Complete comprehensive analysis of test data using statistical tools such as Minitab.
- Perform in-depth interpretation of results and generate detailed technical reports.
- Provide engineering support for pre-clinical trials and commercial readiness.
- Support activities on user evaluation studies to gather insight / feedback on device performance and refine product designs as required.
- Collaborate with delivery system development partners to optimize deployment of next generation valve implant.
- Primary contributor to cross functional team risk management activities (Hazard Analysis/ FMEA) with ownership of implant performance and design actions.
- Contribute to project planning as part of cross-functional team to effectively identify and manage implant schedule, resourcing, and reporting to meet overall project goals.
- Contribute as required to regulatory submissions, pre-submissions, and reviews with implant design and performance expertise.
- Stay up to date with emerging technologies and designs to identify opportunities for innovation and improvement.
- File and capture as appropriate innovative design features through Invention Disclosure Forms and support compilation of patent applications as required.
Skills/Experience
- 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 SolidWorks modelling and engineering drawings.
- Familiarity with application of FEA / CFD towards implant development preferable.
- 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 diligently.
- Technical leadership capability to coordinate efforts of graduate engineers, technicians, and FEA engineers.
For further information contact James Cassidy [email protected] or call in confidence 086 0204322
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