The Human Factors Pre-market Evaluation Team (HFPMET) is a small but growing team of dedicated human factors professionals in the FDA’s Center for Devices and Radiological Health (CDRH), Office of Device Evaluation (ODE). The primary responsibility of HFPMET is to review premarket submissions for new medical devices and combination products. We also participate in human factors-related Standards development, outreach to the manufacturing community and post-market use issues.
We are seeking individuals with strong experience and interest in medical device design and human factors testing. Your efforts will support the Agency’s mission of ensuring that medical devices and combination products sold in the U.S. are safe and effective when used. You will review human factors testing for a variety of medical device types, interact with industry, and contribute to other human factors projects at CDRH.
Qualified candidates will have an advanced degree in human factors or a closely related field and 5-10 years of experience in medical device design and human factors testing and evaluation. Additionally, candidates should possess:
- Familiarity with social science testing theory, research design and application
- An appreciation for the value of medical device regulation, promoting and protecting the health of medical device users and patients in the U.S.
- Excellent verbal and written communication skills and ability to interact in a professional and constructive manner with FDA colleagues and industry representatives
- Willingness to learn the scope of FDA’s regulatory authority and methods for performing reviews of human factors data in device submissions to FDA
- Ability to communicate human factors priorities, methods, and limitations to specialists from other fields
- Ability to understand and work within the challenges inherent to regulating medical device use safety
- Ability to engage in multiple projects simultaneously and meet review deadlines
- Willingness to relocate to the greater Washington, DC metropolitan area
This position will be located at the FDA Headquarters, Silver Spring, Maryland. Please send your current CV or resume to:
Erin Keith, Director (acting), Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices (DAGRID), Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH), Food and Drug Administration. Erin.Keith@fda.hhs.gov, and cc: HFPMET@fda.hhs.gov