The Division of Biomedical Physics of the FDA’s Center for Devices and Radiological Health, Office of Science and Engineering Laboratories has an opening in Silver Spring, MD for a full-time staff scientist/engineer position. The Division conducts research to assess the benefits and risks of using wireless technology in medical devices. We require a candidate specialized in wireless communication to participate in researching novel methods of enabling healthcare applications using wireless technology, defining future research strategy for addressing the use of emerging wireless technology in medical devices, and serving as a technical expert for evaluating the use of wireless technology in medical device regulatory submissions.
To be able to address current and future needs, the candidate should have a strong background in communication theory, radio propagation, and wireless communication systems. The candidate should also be familiar with wide area (e.g., LTE, 5G) and local area (e.g., Wi-Fi and Bluetooth) wireless communication networks.
Although not required, experience with developing, using, or evaluating wireless applications in medical devices is desirable.
The position involves approximately 70% laboratory research and 30% consulting support for reviews of pre-market submissions of new medical devices.
Applicants should possess a Ph.D. or equivalent degree in Engineering, Physics, Mathematics or a related field. Applicants working toward their Ph.D. degree or possessing an M.Sc. degree and a strong record of accomplishments are also encouraged to apply. The applicant must be able to demonstrate accomplishments in the area of wireless communication. This will enable the incumbent to serve as a technical authority in the scientific analysis on the safety and effectiveness of medical devices; provide an authoritative analysis of scientific data submitted to the Agency; and develop new and innovative approaches to scientific testing required for medical device reviews by FDA.
Please document knowledge, skills, and abilities relevant to each area described below:
Experience in the field of wireless communication. Candidates with a background in developing, implementing, modeling, simulating, or testing wireless technology in healthcare applications are preferred.
Strong background in cellular communication systems (e.g., LTE, 5G) or their enabling technologies, and a working knowledge of other wireless communication technologies (e.g., Wi-Fi, Bluetooth, RFID, WMTS).
Experience reviewing, analyzing, and using scientific data relevant to wireless communication technology and a familiarity with data collection and analysis tools (e.g., MATLAB, Python, etc.)
Ability to participate in and contribute to multi-disciplinary teams and work groups to resolve difficult or controversial research and regulatory questions/problems.
Excellent skills in written and oral communication demonstrated through presentations and written materials.
Internal Number: CDRH-OSEL-2020-DBP-NSPE-1
About FDA - Center for Devices and Radiological Health (CDRH)
In keeping with our mission, the Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.
The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advanci...ng regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.
Patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world. The U.S. is the world’s leader in regulatory science, medical device innovation and manufacturing, and radiation-emitting product safety. U.S. post-market surveillance quickly identifies poorly performing devices, accurately characterizes real-world performance, and facilitates device approval or clearance. Devices are legally marketed in the U.S. and remain safe, effective, and of high-quality. Consumers, patients, their caregivers, and providers have access to understandable science-based information about medical devices and use this information to make health care decisions.