Vacancy expired!
- Participate in project team development activities; provide ideas from testing standpoint to help with development efforts -include designing and executing exploratory tests to home in on the best design option.
- Coordinate with project leaders and conduct technical design reviews to drive project to a conclusion.
- Design and execute tests to verify products against requirements.
- Perform data analysis to support test conclusions.
- Design and author and execute test plans/protocols and test reports.
- Own closure of the Design Trace Matrix, working closely with Engineering and Quality to prepare a complete Verification and Validation package.
- Develop clinically relevant experimental testing and computational models that reproduce failure modes observed with product use. Areas of focus will be vascular access and deliverability, blood compatibility, hemodynamics, and anatomic fit.
- Participate in guidance document and standards creation processes with FDA/industry/academia
- Contribute to test methodology development and best practices.
- Conduct or supervise standard tests as required.
- BS required in engineering or science discipline (or equivalent in experience), MS in engineering preferred
- Experience and ability interacting with FDA and other regulatory agencies.
- Hands on with developing and using test equipment.
- Passionate about knowing how and why things fail.
- Passionate about improving the performance of existing products.
- Ability to write clear and understandable technical articles
- Some programming experience preferred
Vacancy expired!