The Food and Drug Administration - Protecting and Promoting YourHealth
Help protect public health by joining the FDA's Center for Devices & Radiological Health (CDRH). From reviewing applications for innovative medical devices to educating industry on relevant policies and regulations to providing accurate, science-based health information to the public, CDRH is at the forefront of in ensuring the safety, efficacy, and security of the medical devices and radiation-emitting products that millions of Americans use daily.
Please Note: This announcement is an open continuous announcement, which means that it is open for a longer period of time and certificates will be pulled at various intervals as needed. There is no guarantee if or when a particular opening might become available.
If you previously applied to this announcement, there is no need to reapply. You are welcome to update your application package, if you so choose, however. You may do so by returning to Application Manager as outlined in the "How To Apply" section of this announcement.
One or more positions may be filled using this vacancy announcement. While most positions are expected to be filled in the Office of Device Evaluation, other Offices within CDRH may use this announcement to fill positions, as well.
- Not Required
In order to be qualified for this position, you must meet the basic requirement in one of the following ways:A. Have successfully completed a four year course of study leading to a Bachelor's or higher degree in professional engineering from a school of engineering with at least one curriculum accredited by the Accreditation Board for Engineering and Technology (ABET) as a professional engineering curriculum. - OR - B. Have successfully completed a four year course of study leading a Bachelor's degree in professional engineering that included differential and integral calculus and courses (more advanced than first-year physics and chemistry) in five of the following seven areas of engineering science or physics: (a) statics, dynamics; (b) strength of materials (stress-strain relationships); (c) fluid mechanics, hydraulics; (d) thermodynamics; (e) electrical fields and circuits; (f) nature and properties of materials (relating particle and aggregate structure to properties); and (g) any other comparable area of fundamental engineering science or physics, such as optics, heat transfer, soil mechanics, or electronics. - OR - C. Possess a current registration as a professional engineer by any State, the District of Columbia, Guam, or Puerto Rico. - OR - D. Have passed the Engineer-in-Training (EIT) examination, and in addition, have a combination of education in the field of general engineering and professional engineering experience which totals at least four years. - OR - E. Have completed at least 60 semester hours of course work in the physical, mathematical and engineering sciences. This course work included differential and integral calculus, as well as courses in at least five of the seven areas listed in response (B). Also, have professional general engineering experience which, when combined with my education as described above, totals at least four years. - OR - F. Have a Bachelor's or higher degree in engineering technology, chemistry, physics, architecture, computer science, mathematics, hydrology, geology, or another scientific field directly related to engineering. In addition, have at least one year of professional engineering experience acquired under professional engineering supervision and guidance. In addition, in order to qualify at the GS-12 level, you must possess one year of specialized experience, equivalent to the GS-11 level in the Federal service, analyzing scientific data submitted by other scientists/researchers to provide feedback or advice on methods/procedures utilized; conducting research or briefings on the classification and scientific review of medical device products or other scientific systems/designs; modifying existing guidelines and protocols for scientific testing of medical device products or other scientific systems and designs; and providing information to researchers or scientists on guidelines, scientific, or regulatory requirements related to research on scientific products.
In addition, in order to qualify at the GS-13 level, you must possess one year of specialized experience, equivalent to the GS-12 level in the Federal service, reviewing technical or complex data (e.g. related to multi-step processes, combination products, etc.) for scientific/research projects related to the accuracy, safety, or efficacy of a medical device or scientific system/process; providing advice and assistance to scientists in developing scientific and technical policies; reviewing research protocols to evaluate medical device products, scientific projects, or research assignments; and recommending solutions to scientific complaints, research discrepancies, and/or product problems.
ARE YOU USING YOUR EDUCATION TO QUALIFY? You MUST provide transcripts or other documentation to support your educational claims. Unless otherwise stated: (1) unofficial transcripts are acceptable, or (2) you may submit a list with all of your courses, grades, semester, year, and credit for the course. All materials must be submitted by the closing date of the announcement.
Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit:
Only experience obtained by the closing date of this announcement will be considered.
Q - Nonsensitive