Biomedical Engineer
The 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 safe, and effective.
The Center for Devices and Radiological Health (CDRH) 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.
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Major Duties
As a Biomedical Engineer in CDRH you will:
- Recognized scientific and technical expert in the area of software, cybersecurity, electromagnetic compatibility (EMC) and wireless technologies.
- Recommends and develops agency policies and nationwide standards, procedures, and instructions for guiding industry and government agencies.
- 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.
Basic Requirements
Applicants will be required to meet the specific qualification requirements of the following occupational series: Biomedical Engineer.
Additionally, applicants must possess the required specialized experience that equipped them with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled.
Applicants must have one year (52 weeks) of specialized experience equivalent to the GS-13 grade level in the Federal service, experience includes: reviewing scientific data to develop organizational policies and procedures related to digital health, software validation and cybersecurity of medical devices; evaluating the accuracy and reliability of medical device software applications; and analyzing and assessing scientific research findings on software validation and cybersecurity vulnerabilities for networked medical device products.
NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Please see the official job vacancy announcement for: additional information; additional specialized experience, education and qualification requirements.
The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer.