Description
This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 1, Band C.
Duties:
A Regulatory Scientific Reviewer (Biomedical Engineer) integrates engineering principles - spanning mechanical, electrical, chemical, and materials engineering - with biological and medical sciences to analyze, design, and evaluate medical devices, diagnostic systems, and biomedical technologies.
Applies biomechanical, biocompatibility, and systems engineering methods to assess product performance, safety, and fitness for use in clinical and biological environments.
Bridges engineering and medicine to provide the rigorous technical expertise required to evaluate devices and technologies intended for use in the diagnosis, treatment, or monitoring of human health conditions.
Analyzes complex data and guidelines or criteria for scientific review and approval for a class of products.
Identifies risks, gaps, trends, and reviews or coordinates review of important precedent setting scientific issues which establish Agency policy for subsequent reviews of similar products.
Requirements
Conditions of employment
U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
Selective Service Registration: All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Visit www.SSS.gov for more info.
FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.
Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities.
Probationary periods are required for new employees appointed to competitive service positions for the first time; or reinstated employees who return after a break in service of 30-days or more and who have not completed a probationary period.
Financial Disclosure may be required.
Ethics Clearance may be required.
Qualifications
The position of Regulatory Scientific Reviewer (Biomedical Engineer) falls under the 0858 occupational series. To qualify for this position at grade AD-00, you must meet all requirements by 11:59 pm EST on 08/07/2026.
Basic Requirements: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0800/files/all-professional-engineering-positions-0800.pdf
A. Degree: Engineering. To be acceptable, the program must:(1) lead to a bachelor's degree in a school of engineering with at least one program accredited by ABET; or (2) include 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
B. Combination of education and experience -- college-level education, training, and/or technical experience that furnished (1) a thorough knowledge of the physical and mathematical sciences underlying engineering, and (2) a good understanding, both theoretical and practical, of the engineering sciences and techniques and their applications to one of the branches of engineering. The adequacy of such background must be demonstrated by one of the following: 1. Professional registration or licensure -- Current registration as an Engineer Intern (EI), Engineer in Training (EIT)1 , or licensure as a Professional Engineer (PE) by any State, the District of Columbia, Guam, or Puerto Rico. Absent other means of qualifying under this standard, those applicants who achieved such registration by means other than written test (e.g., State grandfather or eminence provisions) are eligible only for positions that are within or closely related to the specialty field of their registration. For example, an applicant who attains registration through a State Board's eminence provision as a manufacturing engineer typically would be rated eligible only for manufacturing engineering positions. 2. Written Test -- Evidence of having successfully passed the Fundamentals of Engineering (FE)2 examination or any other written test required for professional registration by an engineering licensure board in the various States, the District of Columbia, Guam, and Puerto Rico. 3. Specified academic courses -- Successful completion of at least 60 semester hours of courses in the physical, mathematical, and engineering sciences and that included the courses specified in the basic requirements under paragraph A. The courses must be fully acceptable toward meeting the requirements of an engineering program as described in paragraph A. 4. Related curriculum -- Successful completion of a curriculum leading to a bachelor's degree in an appropriate scientific field, e.g., engineering technology, physics, chemistry, architecture, computer science, mathematics, hydrology, or geology, may be accepted in lieu of a bachelor's degree in engineering, provided the applicant has had at least 1 year of professional engineering experience acquired under professional engineering supervision and guidance. Ordinarily there should be either an established plan of intensive training to develop professional engineering competence, or several years of prior professional engineering-type experience, e.g., in interdisciplinary positions. (The above examples of related curricula are not all inclusive.)
Minimum Qualifications:
Comparable experience is experience that equipped the applicant with the 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. The relevant experience must demonstrate one year of full-time work experience, or the equivalent if part-time (for example, an employee working 20 hours per week for a 12-month period should be credited with 6 months of experience). Experience may have been obtained in either the federal service or its equivalent with state or local government, the private sector, or nongovernmental organizations.
AND
IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS:
Have a bachelor's degree and have 4 years of comparable experience in conducting scientific or regulatory review, resolving complex technical issues, and establishing policy and review standards.
OR
Have a master's degree and have 3 years of comparable experience in conducting scientific or regulatory review, resolving complex technical issues, and establishing policy and review standards.
OR
Have a Doctorate/PhD and/or J.D. degree and have 1 year of comparable experience in conducting scientific or regulatory review, resolving complex technical issues, and establishing policy and review standards.
OR
Have a MD, DO, DDS, DPM, or DVM degree.
OR
Have 6 years of comparable experience in conducting scientific or regulatory review, resolving complex technical issues, and establishing policy and review standards.
The following skills and experiences are highly desirable, though not required:
Characterization and measurement of electromagnetic fields in the MR environment. Phantom-based measurements of implant heating under radiofrequency exposures. Computational modeling of electromagnetic fields and bioheat transfer. Development and/or use of virtual anatomical tissue and patient models.
Familiarity with MR safety standards used in medical device evaluation, such as ISO/TS 10974 or ASTM F2182.
NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, https://secure.login.gov/, select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Be sure that any uploaded documents you provide in your application are free of document security or compression which might render the document unreadable by our system.
IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume.
