Regulatory Scientific Reviewer; Biomedical Engineer

Summary

The position of Regulatory Scientific Reviewer (Biomedical Engineer) falls under the 0858 occupational series in the Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories. The role is hiring under Title 21 Pay Table 1, Band

C.

• Conduct scientific or regulatory review of biomedical engineering products.
• Resolve complex technical issues related to device safety and efficacy.
• Establish policy and review standards for medical devices.
• Collaborate with regulatory scientists and industry stakeholders.

• Degree in Engineering from a program accredited by ABET or equivalent coursework in core engineering sciences.
• Professional registration or licensure as an Engineer Intern (EI), Engineer in Training (EIT), or Professional Engineer (PE); or evidence of passing a relevant Fundamentals of Engineering examination.
• At least 60 semester hours of acceptable engineering courses, or a related bachelor’s degree with one year of professional experience under supervision.

• 4 years of comparable experience in conducting scientific or regulatory review with a bachelor’s degree, or
• 3 years of comparable experience with a master’s degree, or
• 1 year of comparable experience with a Doctorate/PhD or JD, or
• 6 years of comparable experience with no advanced degree.
• Experience may be from federal service, state or local government, private sector, or non‑governmental organizations.

• Planning and conducting human subjects research for wearable sensor‑derived endpoints, including movement and gait analysis.
• Analyzing physiologic signals such as electrocardiograms, photoplethysmography, and inertial measurement units.
• Applying signal processing and artificial intelligence/machine learning methods.
• Cyber‑physical testing of medical device systems.
• Knowledge of medical device data interfaces and interoperability standards (e.g., IEEE 11073 series).

Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories (OSEL), FDA. The position is located in Washington, D.C.