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.
As an Engineer in CDRH you will:
- Obtain and review technical literature or data to determine the safety, efficacy, and degree of risk of medical devices to the public health;
- Participate in the interpretation and review of scientific data to determine its validity and scientific significance;
- Assist in the review of technical data submitted with respect to accuracy, precision, and reliability and renders scientific decisions;
- Assist the senior scientists in editing and correcting memorandum, scientific report and other technical documents;
- Assist in responding to inquiries and Freedom-of-Information requests regarding medical devices; and
- Conduct literature searches for senior scientists/reviewers and prepares summaries.
In addition to the eligibility requirements for the Pathways Recent Graduate Program, applicants will be required to meet the specific qualification requirements of the following occupational series: General Engineering (0801); Mechanical Engineering (0830); Electrical Engineering (0850); Bioengineering and Biomedical Engineering (0858).
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-05 grade level in the Federal service, experience includes: performing literature reviews to gather information used for regulatory or scientific purposes; conducting analyses of scientific data; and preparing reports or presentations related to the results of scientific tests or studies. -OR-
B. Completion of one year of graduate level education related to the position being filled (Engineer) from an accredited college and/or university.-OR-
C. A bachelor’s degree as described in the Basic Qualification Requirements above AND meet Superior Academic Achievement provision (S.A.A.) criteria (visit the site for more detail information). S.A.A. is based on (1) class standing, (2) grade-point average, or (3) honor society membership. -OR-
D. Have a combination of experience as described in “A” above and education as described in “B” above, that when combined equals 100% of the total requirements.-OR-
E. Have an engineering bachelor’s degree AND have appropriate specialized experience as an Engineering Technician;-OR-
F. Have successfully completed a 5-year program of study of at least 160 semester hours leading to a bachelor’s degree in engineering.
A. Applicants must have at least one full year of specialized experience, equivalent to the GS-07 grade level in the Federal service which includes performing literature reviews to gather information used for regulatory or scientific purposes; reviewing and evaluating scientific data to determine accuracy and completeness; and preparing reports or presentations related to the results of scientific tests or studies.;-OR-
B. Have 2 years of years of progressively higher level graduate education leading to a master’s degree in Engineering or master’s or equivalent graduate degree;-OR-
C. Have a combination of superior academic achievement AND one (1) year of appropriate specialized Engineering experience;-OR-
D. Have successfully completed a 5-year program of study of at least 160 semester hours leading to a bachelor’s degree in engineering AND have one (1) year of appropriate professional Engineering experience.
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.