Job Overview

Summary

Become a part of the Department that touches the lives of every American!  At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere.  It is the principal agency for protecting the health of citizens.  Join HHS and help to make our world healthier, safer, and better for all Americans.

This position is located in the Department of Health and Human Services (FDA), Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Labs (OSEL), in Silver Spring, MD.

This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-MP-13-913146 under merit promotion procedures.  Please review that announcement to see if you are eligible for consideration under merit promotion procedures.  NOTE:  Applicants must apply separately for each announcement in order to be considered.

Who May Apply:  Open to all United States Citizens.

This announcement may be used to fill additional vacancies.

Duties

The incumbent reviews scientific data submitted in support of a variety of medical device submissions such as premarket applications (PMAs), product development protocols (PDPs), applications for investigational device exemptions (IDEs), premarket notifications (501(k)s) of intent to market a device, and reports such as establishment inspection reports (IRRs), to determine if a regulatory decision of safety and effectiveness of the device can be made.  Independently designs and conducts experimental and theoretical studies to evaluate the performance of medical devices and radiological products. Develops tests and methodologies for measuring or assuring compliance with developed standards in support of national regulatory programs. Develops models to determine optimal device features. Develops tests and methodologies for measuring or assuring compliance with developed standards in support of national regulatory programs. Assesses the safety and effectives of medical devices in support of FDA regulatory programs through direct product testing and review of data from product manufacturing. Develops new or modifiers existing methods to evaluate new products seeking marketing approval. Plans and conducts state-of-the-art scientific testing for performance and safety and researches causes of device failure and potential hazards. Reviews scientific data submitted in support of a variety of medical device submissions such as premarket . Reviews research protocols to evaluate medical devices. Writes and evaluates organization-wide guidelines concerning the data required in submissions to the organization for medical devices and their marketing, makes presentations to the medical and scientific experts.