Deputy Office Director (Supervisory Biomedical Engineer)
What you'd do
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 F.
Major duties
Serves as top scientific and technical expert and advisor and is nationally and internationally recognized authority in professional healthcare and medical related work spanning multiple disciplines with the health sciences. Provide scientific and technical leadership and guidance on regulations and policy issues, and federal laws (including the Food, Drug, and Cosmetic Act). Oversee OCEA regulatory and scientific work including developing policy and program support regarding clinical evidence, supporting device reviews that require expert clinical and real-world evidence analysis, and providing data infrastructure, management and analysis for clinical and real-world evidence. Provide scientific and technical consultation to the OCEA Director and other high-level officials in CDRH, FDA, PHS and HHS on program status, plans, trends and significant problems. Leads, manages and sets strategy for the OCEA. Ensures that OCEA activities are aligned with the goals and priorities of OPEQ. Supervisory Responsibilities: Provides technical, policy and administrative leadership, supervision and direction to the subordinate staff of the Office through subordinate supervisors. Exercises the full range of first and second-level supervisory responsibilities. Exercises significant responsibilities in dealing with officials of other units or organizations, or in advising management officials of higher rank. Works with the Office Director on the development, establishment, and clearance of goals, objectives, and strategic plans for the Office.
What you need to qualify
In order to qualify for the Deputy Office Director (Supervisory Biomedical Engineer) position which falls under the 0858 occupational Series, you must meet the following requirements by 11:59 pm EST on 08/24/2026: 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.) 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 7 years of comparable experience providing scientific and technical leadership and oversight for clinical evidence and analysis programs supporting medical device regulation; serves as technical authority in clinical evidence evaluation, regulatory science, or engineering; oversees and directs comprehensive scientific reviews of clinical data, real-world evidence, and regulatory submissions related to medical device safety and effectiveness. OR Have a master's degree and have 6 years of comparable experience providing scientific and technical leadership and oversight for clinical evidence and analysis programs supporting medical device regulation; serves as technical authority in clinical evidence evaluation, regulatory science, or engineering; oversees and directs comprehensive scientific reviews of clinical data, real-world evidence, and regulatory submissions related to medical device safety and effectiveness. OR Have a Doctorate/PhD and/or J.D. degree and have 4 years of comparable experience providing scientific and technical leadership and oversight for clinical evidence and analysis programs supporting medical device regulation; serves as technical authority in clinical evidence evaluation, regulatory science, or engineering; oversees and directs comprehensive scientific reviews of clinical data, real-world evidence, and regulatory submissions related to medical device safety and effectiveness. OR Have a MD, DO, DDS, DPM, or DVM degree and have 4 years of comparable experience providing scientific and technical leadership and oversight for clinical evidence and analysis programs supporting medical device regulation; Serves as technical authority in clinical evidence evaluation, regulatory science, or engineering; Oversees and directs comprehensive scientific reviews of clinical data, real-world evidence, and regulatory submissions related to medical device safety and effectiveness. OR Have 11 years of comparable experience providing scientific and technical leadership and oversight for clinical evidence and analysis programs supporting medical device regulation; Serves as technical authority in clinical evidence evaluation, regulatory science, or engineering; Oversees and directs comprehensive scientific reviews of clinical data, real-world evidence, and regulatory submissions related to medical device safety and effectiveness. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
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