Transformative Vascular Device Engineer
We seek an accomplished device engineer to lead the development of a Class III implantable device. This impactful project will progress through clinical studies, PMA submission, and global commercialization.
Key Responsibilities:
* Oversee the design and development of the delivery system for an aortic stent graft from concept to commercialization.
* Manage and mentor a team of engineers to drive innovation.
* Drive structured project execution across design, verification, validation, and regulatory milestones.
* Collaborate with cross-functional teams to ensure alignment with FDA Class III device requirements and PMA strategy.
Requirements:
* Advanced degree in Biomedical Engineering, Mechanical Engineering, or Materials Science.
* Minimum 5 years' experience in medical device engineering, specifically Class III implantable devices.
* Proven expertise in vascular technologies, ideally with aortic stent grafts, or alternatively in coronary stents/stent grafts.
* Demonstrated leadership experience, with ability to delegate, motivate, and guide teams through full product lifecycle.
Benefits:
* Opportunity to make a transformative impact in the medical device industry.
* Chance to work on a high-impact project that will drive innovation and improvement.