About the role:
This Senior Design Assurance Engineer position presents an opportunity to leverage expertise in design assurance and risk management to support R&D teams across various projects. The successful candidate will provide strategic guidance on design updates, ensuring alignment with evolving standards and regulatory requirements while maintaining integration into our Quality Management System (QMS).
The ideal candidate will have a Bachelor's degree in Engineering or a related field, accompanied by a minimum of 5 years' relevant experience in the medical device industry, preferably with exposure to stent technologies or Class III devices in a Design Assurance capacity.
Key responsibilities include interpreting regulatory requirements for device development, leading risk management processes for assigned projects, driving Human Factors and Usability Engineering activities, and developing and validating test methods to support R&D efforts.