Director, Office of Science and Engineering Laboratories (OSEL)

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 4, Band G.

Duties

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• Provides executive leadership overseeing multidisciplinary programs in physical sciences, engineering, biological sciences, and computational science applied to the safety and effectiveness of medical devices and radiation-emitting products.
• Set scientific strategy for OSEL, aligning priorities with CDRH and FDA-wide goals and anticipating emerging technologies and regulatory challenges.
• Lead cutting-edge research programs that develop the test methods, measurement frameworks, computational models, and scientific tools that underpin FDA's regulatory decisions.
• Advise senior leadership, including the CDRH Director, on significant scientific and engineering matters affecting medical device regulation.
• Shape regulatory science as a discipline by establishing novel frameworks and methodologies adopted across FDA and by domestic and international regulatory partners.
• Build strategic partnerships with federal agencies, industry, standards organizations, international counterparts, and academia.
• Manage a highly skilled workforce spanning multiple laboratories and scientific disciplines.

Requirements

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Conditions of employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service.
• 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.
• Males born after December 31, 1959, must be registered with the Selective Service. Please go to http://www.sss.gov for more information.
• 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.
• Ethics Clearance and Financial Disclosure is required

Qualifications

In order to qualify for the Director, Office of Science and Engineering Laboratories (OSEL) position which falls under the 0801 occupational Series, you must meet the following requirements by 11:59 pm EST on 10/28/2026:

The candidate must meet the following qualifications for this Title 21 position:

1. Scientific, Technical, and/or Professional Fields
2. Qualified and Outstanding Candidates

a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the technical qualifications defined below as a baseline for comparing experience levels and other candidate attributes for relevant positions

b, Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.

Basic 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 1 For more information about EI and EIT registration requirements, please visit the National Society of Professional Engineers website. The FE examination is not administered by the U. S. Office of Personnel Management. For more information please visit: http://www.nspe.org/Licensure/HowtoGetLicensed/index.html.2 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, maybe 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.

Desired Qualifications:

• Possesses a Ph.D. in the life sciences or an M.D./Ph.D. degree, with advanced research and scientific training relevant to the position.
• The preferred qualification reflects the depth of research expertise needed to lead multidisciplinary regulatory science programs and address complex scientific and emerging technologies.
• An M.D. without a Ph.D. is not considered equivalent to the preferred research and scientific background.

This position is designated as an SES Equivalent position and is covered under the FDA Title 21 Executive Performance Management System and identified as a public filing position for ethics purposes.

While PHS Commissioned Corps Officers cannot hold a Title 21 position during their active service as PHS Officers, we welcome and encourage them to apply-their applications will receive full consideration. Please note that if selected, the Officer will need to end their Commissioned Corps appointment before being placed in the Title 21 position.

Supervisory Responsibilities The incumbent is delegated full authority to achieve group goals and objectives through the effective management of available resources. Performance and accomplishments are assessed primarily through work performance indicators, staff discussion, planning sessions, review of individual project outputs, and annual program review.

Leads in a proactive, customer-responsive manner consistent with Agency vision and values, effectively communicating program issues to external audiences. Ensures financial and managerial accountability by acting with prudence when executing fiduciary responsibilities. Demonstrates high integrity and adheres to the highest ethical standards of public service. Uses effective business practices including balanced measures of results, values, and invests in each employee; emphasizes empowerment and two-way communication. Takes a leadership role in advocating for and advancing the priorities of the Agency. Serves as a role model for leadership by encouraging teamwork and a collaborative approach. Timely notifies Agency officials of all significant actions and developments, including but not limited to those related to regulatory matters, legislative matters, budget matters, reports, initiatives, and events and ensures subordinate managers do the same.

Provides reasonable accommodations needed to best utilize qualified people with disabilities.

Organizational Management: Manages the Office of Science and Engineering Laboratories (OSEL) within CDRH

Program Management: Runs a multidisciplinary regulatory science program in the Center encompassing multiple laboratories and scientific disciplines. Directs and evaluates activities addressing scientific and technical questions relevant to medical devices and radiation-emitting products, including test methods, biocompatibility, biological testing, in vitro/in vivo evaluation, computational modeling, and reference materials.

Resource Management: Monitors and reports on resources needed to lead strategic resource planning for OSEL and its multidisciplinary regulatory science programs. Establishes annual and multi-year objectives, determines program priorities, and allocates resources across OSEL's scientific programs.

Human Capital Management: Identifies employee competencies necessary to meet OSEL's organizational capabilities goals across its multidisciplinary scientific workforce. Designs competency frameworks and workforce architecture to ensure OSEL maintains the scientific capabilities needed for current and emerging regulatory science challenges.

Education

NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.

TRANSCRIPTS (Required): Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.

If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.

Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.

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 the U.S. Department of Education website for Foreign Education Evaluation.

To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery