Job Title: Principal Heart Valves Engineer
We are seeking a lead heart valve implant engineer to join our team and work on the development of a breakthrough heart valve replacement.
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 standards 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 the 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 the 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.
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 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.