Description
The role leads planning and coordination of use-related risk analysis across assigned pharmaceutical, medical device, or combination-product programs, while supporting systems engineering activities such as requirements definition, traceability, risk assessments, FMEAs, change management, and third-party development oversight. The position requires expertise in DHF management, design control, human factors, risk management, and regulated-product development, along with strong cross-functional communication, project-management, analytical, and vendor-management skills. Education and experience requirements include a BS in Engineering, Science, or a closely related discipline with 10 years of relevant experience, or an MS with 8 years of experience.
