Friday 5th August 2022
Organization The U.S. Food and Drug Administration (FDA)
Location Silver Spring, MD, USA
Title Staff Fellow
Email Address CDRH-OSEL-DIDSR.VMAIL@fda.hhs.gov
Description Position Title Code: AIDM
Location: Silver Spring, Maryland
Application Period: (open)
Salary Range: (commensurate with education/experience) Position Information: Full-time term appointment (3 years with possibility of extension). Open to US Citizens; Permanent Residents; and Non-Citizens.
The U.S. Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe and effective. The mission of the Center for Radiological Health (CDRH) is to protect and promote the public health by ensuring safety and effectiveness of medical devices. The Office of Science and Engineering Laboratories (OSEL) is dedicated to promoting innovation for the development of new lifesaving medical devices. OSEL is composed of scientists and engineers who conduct regulatory science research and have a broad diversity of expertise from microbiology to artificial intelligence and machine learning. The Division of Imaging, Diagnostics, and Software Reliability (DIDSR) within CDRH’s OSEL develops methods for evaluating the image quality of emerging imaging systems including in silico trial methods, develops methods for characterizing new medical image display devices, develops methods for the evaluation of medical extended reality devices, evaluates dose reduction of image reconstruction methods and assesses the performance artificial intelligence and machine learning algorithms.
Position Title: Advanced methods for diagnostics and imaging
Assignment: DIDSR is accepting applications for full-time scientific staff positions to lead regulatory science efforts in the development and assessment of advanced diagnostics and medical imaging devices. The selected staff will participate in the regulatory review of emerging technologies and conduct regulatory science research in areas of immediate interest including:
• evaluation methodologies for monitoring of AI/ML device performance drifts in real-world, post-market settings,
• methodologies for regulatory assessment of AI equity: tools for collecting and analyzing subpopulation-level performance in pre- and post-market settings,
• MR physics and deep-learning reconstruction, and,
• imaging devices for point-of-care and home-use digital health applications (including medical ultrasound applications and skin lesion computer analyzers).
These efforts contribute to the regulatory science around emerging AI/ML techniques in medical devices and prepare the Agency for the regulatory evaluation of related products. Candidates with a strong background in theoretical, computational and experimental aspects are preferred.
How to Apply: Documents to submit include resume or curriculum vitae, cover letter describing why you are uniquely qualified for this position, and transcripts. Compile all applicant documents into one and email package to CDRH-OSEL- DIDSR.VMAIL@fda.hhs.gov. A USAJOBS entry will be available soon. Please refer to LinkedIn posting for full details. https://www.linkedin.com/feed/update/urn:li:activity:6952976987984416769?utm_source=linkedin_share&utm_medium=member_desktop_web