Senior Implant Engineer
This is a unique opportunity to lead the development of breakthrough heart valve replacement devices from concept through to clinical studies.
The ideal candidate will have expertise in material development, nitinol, and valve interface requirements to drive design and development activities. Strong understanding of regulatory requirements per ISO 5840 and clinical end user needs is essential.
Main Responsibilities:
* Leverage expertise in material science to develop innovative implant designs.
* Ensure all designs meet required regulatory requirements and clinical end user needs.
* Generate detailed component and subsystem drawings/designs using SolidWorks.
* Lead and mentor postdoctoral research candidates engaged in implant development activities.
* Maintain detailed records of design iterations, evaluations, test methods, and analysis.
* Create prototypes and design iterations, conducting feasibility studies to evaluate valve designs and materials.
* Develop effective bench test methods, including hands-on testing and builds.
* Maintain high standards of documentation throughout project phases.
* Generate R&D test protocols and technical reports.
* Analyze test data using statistical tools like Minitab and provide detailed technical reports.
* Provide engineering support for pre-clinical trials and commercial readiness.
* Support user evaluation studies to gather insight/feedback on device performance and refine product designs as needed.
* Collaborate with delivery system development partners to optimize deployment of next-generation valve implants.
* Contribute to cross-functional team risk management activities (Hazard Analysis/FMEA) with ownership of implant performance and design actions.
* Stay up-to-date with emerging technologies and designs to identify opportunities for innovation and improvement.
* Foster a culture of innovation and excellence within the team.
Qualifications/Skills:
* 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 FEA/CFD application towards implant development (preferable)
* Direct Class III implant design experience
* Understanding of regulatory requirements (ISO 5840, ISO 13485, FDA regulation)
About This Opportunity
This role offers a unique chance to make a meaningful impact in the field of heart valve replacement technology. As a Senior Implant Engineer, you will be responsible for leading the development of innovative implant designs that meet the needs of patients and healthcare professionals alike.