This position is located in the Food and Drug Administration, Center for Devices and Radiological Health (CDRH). 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.
As an Engineer in CDRH you will:
- Review scientific data submitted in support of a variety of medical device submissions to determine the safety and effectiveness.
- Review data in the field of general engineering, summarizes it and makes recommendation concerning the data, also provides leadership and guidance in general engineering to other supporting level scientists.
- Provide scientific information and consultation to industry, academic, and private laboratory scientists conducting research on the safety and effectiveness of materials used in the manufacture of medical device products or other scientific systems.
Applicants will be required to meet the specific qualification requirements of the General Engineer (0801) occupational series.
Specialized experience is experience that equipped the applicant 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.
For the GS-11 you must have one year (52 weeks) of specialized experience equivalent to the GS-09 grade level in the Federal service:
- Preparing, presenting, and/or defending findings on scientific research
- Providing consultation to industry, academic and/or private laboratory scientists; and
- Reviewing scientific data and determine project technical needs.
- 3 years of progressively higher level graduate education leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree
For the GS-12 you must have one year (52 weeks) of specialized experience equivalent to the GS-11 grade level in the Federal service that includes:
- Evaluating the accuracy, precision, and/or reliability of products such as medical devices and/or radiological products; and
- collaborating with other scientists, engineers, and/or healthcare professionals within an organization/agency on a wide range of scientific and regulatory issues.
For the GS-13 you must have one year (52 weeks) of specialized experience equivalent to the GS-12 grade level in the Federal service that includes:
- Advising on compliance and/or regulatory policy developments
- Preparing and presenting briefings to senior level management and recommending program enhancements; and
- Developing, modifying, and/or evaluating guidelines concerning data required in products such as medical devices and/or radiological products.
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.