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.
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 07/14/2025: Basic Qualification Requirements: 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 I 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.
Conducts reviews using scientific specialty for pre- and post-market submissions related to the safety and efficacy of medical devices. Collaborates with review teams and exercises discretion and judgement in the scientific review of data submissions. Develops reports and recommendations for regulatory and scientific evaluation of medical and radiological product information and submissions. Reviews research protocols to evaluate medical and radiological products. Develops and proposes new review practices, policies, guidance documents, and regulations within area of knowledge or expertise.