Biomedical Engineer
Summary
This position is located in the Center for Devices and Radiological Health (CDRH) which assures that patients and providers have timely and continued access to safe, effective and high-quality medical devices and safe radiation-emitting products. CDRH facilitates 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.
Responsibilities
- Recommends and develops agency policies and nationwide standards, procedures, and instructions for guiding industry and government agencies.
- Recognized scientific and technical expert in the area of software, cybersecurity, electromagnetic compatibility (EMC) and wireless technologies.
- Reviews (particularly in relation to the design and validation of software and cybersecurity of networked medical devices) or directs a team effort in the review of scientific and technical data.
- Provides information to individuals, government agencies, private industry, universities and foreign government on the safety and effectiveness of components of and policy concerning software, networked devices, and cybersecurity vulnerabilities.
- Presents scientific reports to the medical and scientific experts who serve as panel members of the Food and Drug Administration Advisory Committee.