Department of Health and Human Services

Biomedical Engineer

Silver Spring, Maryland Full time

Biomedical Engineer

Department: Department of Health and Human Services

Location(s): Silver Spring, Maryland

Salary Range: $143913 - $197200 Per Year

Job Summary: 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 D.

Major Duties:

  • Reviews and determines the safety and efficacy of highly complex radiological health devices and products across the total product lifecycle. Directs reviews of pre- and post-market files related to the safety and efficacy of products within and across product specific divisions and offices. Serves as the lead technical authority and subject matter expert (SME) and utilizes biotechnology to improve and provide healthcare systems and devices, and/or a variety of medical and radiological health products. Provides guidance to field personnel in areas related to industry manufacturing processes for clinical, medical, and radiological products. Leads public health communication efforts regarding the safety and effectiveness of medical and radiological devices and products.

Qualifications: In order to qualify for the Biomedical Engineer position which falls under the 0858 occupational Series, you must meet the following requirements by 11:59 pm EST on 03/11/2026: Basic Qualification 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: Relevant 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 5 years of comparable experience serving as a lead technical authority and subject matter expert (SME) utilizing biotechnology to improve healthcare systems in addition to being responsible for reviewing and determining the safety and efficacy of highly complex radiological health devices and products across the total product lifecycle. OR Have a master's degree and have 4 years of comparable experience serving as a lead technical authority and subject matter expert (SME) utilizing biotechnology to improve healthcare systems in addition to being responsible for reviewing and determining the safety and efficacy of highly complex radiological health devices and products across the total product lifecycle. OR Have a Doctorate and/or J.D. degree and have 2 year of comparable experience serving as a lead technical authority and subject matter expert (SME) utilizing biotechnology to improve healthcare systems in addition to being responsible for reviewing and determining the safety and efficacy of highly complex radiological health devices and products across the total product lifecycle. OR Have a MD, DO, DDS, DPM, or DVM degree and 2 years of experience serving as a lead technical authority and subject matter expert (SME) utilizing biotechnology to improve healthcare systems in addition to being responsible for reviewing and determining the safety and efficacy of highly complex radiological health devices and products across the total product lifecycle. OR Have 7 years of comparable experience serving as a lead technical authority and subject matter expert (SME) utilizing biotechnology to improve healthcare systems in addition to being responsible for reviewing and determining the safety and efficacy of highly complex radiological health devices and products across the total product lifecycle. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.

How to Apply: In accordance with Executive Order 14170, applicants are encouraged to respond to the four short, free-response, essay questions in the questionnaire. Answers to these questions are optional and will not be scored or rated. Your answers will be reviewed by the hiring manager and agency leadership if you are referred for selection consideration. You will be asked to certify that your responses are written in your own words and that you did not use a consultant or artificial intelligence (AI) tool (such as ChatGPT or Copilot). Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution. To apply for positions with the Food & Drug Administration, you must have a https://secure.login.gov/ account, and be signed in to that account, before you click "Apply Online". See the USAJOBS Help Site article "How does the application process work?" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 03/11/2026. We recommend that you start the application process early enough that you can complete and submit your application before this deadline. Please note that you cannot submit documentation or make changes to your application after the close date. If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: https://help.usajobs.gov/how-to. Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Contact us at: USAJOBS - Contact us FDA's Applicant Help Desk is not able to support USAJOBS-related issues. The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or you encounter any difficulty with the site, we recommend that you visit the Applicant HELP Site at: https://appsupport-usastaffing.opm.gov/hc/en-us. This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you! You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis. If after reviewing the USAJOBS and Application Manager help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 866-807-3742, or e-mail ERIC@fda.hhs.gov. The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 12899437 so that we may assist you faster.

Application Deadline: 2026-03-11