Duties

• This position(s) is located in the Food and Drug Administration (FDA), Center for Devices and Radiological Heath (CDRH), Office of Product Quality and Assessment (OPEQ). As a Scientific Reviewer (Staff Fellow) in OPEQ, you will:
• Review scientific data submitted in support of a variety of medical device submissions to determine the safety and effectiveness.
• Review data in the field of general engineering, summarizes it and makes recommendation concerning the data, also provides leadership and guidance in general engineering to other supporting level scientists.
• Provide scientific information and consultation to industry, academic, and private laboratory scientists conducting research on the safety and effectiveness of materials used in the manufacture of medical device products or other scientific systems.
• Utilize knowledge and experience to inform scientific and regulatory decisions regarding the safety and effectiveness of new and existing in medical devices as an integral member of multidisciplinary review teams;
• Prepare oral and written communications of review recommendations; Effectively communicate within FDA, with device manufacturers, and with other public health stakeholders;
• Advance knowledge and keep abreast of latest scientific trends, technologies, and techniques related to areas of expertise.

Requirements

Conditions of Employment

• Public Filer financial disclosure statement required, see the Additional Information section for details!
• Males born on, or after, December 31st 1959 must be registered with the Selective Service System or have an approved exemption. Visit www.SSS.gov for more info.
• Background and/or Security investigation required, see the Additional Information section for details!
• Prohibited financial interest restrictions apply, see the Additional Information section for details!
• Veterans Preference DOES NOT APPLY to positions, such as this one, advertised under Title 42-G hiring regulations.

Qualifications

BASIC QUALIFICATION REQUIREMENTS:
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

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.

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.
Minimum Qualifications for RG-00 (Equivalent to GS-13):
You must possess one year of experience, equivalent to the GS-12 level in the Federal service, experience includes: advising on compliance and/or regulatory policy developments; preparing and presenting briefings to senior level management and recommending program enhancements; and developing, modifying, and/or evaluating guidelines concerning data required in products such as medical devices and/or radiological products.

Desirable Education: A doctoral-level degree from an accredited institution of higher learning, such as a Ph.D. or D.V.M., or other research doctoral-degree widely recognized in U.S. academe as equivalent to a Ph.D.

Education

You must submit an official transcript, unofficial transcript or a list of courses to include, grade earned, completion date(s) and quarter semester hours earned.

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 .

Additional information

Additional Conditions of Employment:

Security and Background Requirements: This position requires a Security Clearance . If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication of a Secret Clearance. Failure to successfully meet these requirements may be grounds for appropriate personnel action. Applicants are also advised that all information concerning qualification is subject to investigation. False representation may be grounds for non-selection and/or appropriate disciplinary action. Failure to obtain and maintain the required level of clearance may result in the withdrawal of a position offer or removal.

Political Appointees: If you are serving, or have served in the last 5 years (from 01/19/2018) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. See the OPM page Political Appointees FAQ for more.

E-Verify: The U.S. Department of Health and Human Services is an E-Verify Participant. If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system.

Financial disclosure statement may be required. FDA inspires public confidence by maintaining high ethical principles, and all Federal Government employees are subject to the conflict of interest statutes and regulations, including the Standards of Ethical Conduct, that govern activities with outside organizations and reporting financial holdings. Certain positions within the FDA are subject to strict restrictions on financial holdings (FDA regulated financial holdings). The Ethics in Government Act, PL 95-521 also requires the applicant selected for this position to submit a Public Financial Disclosure Report, OGE-278, prior to assuming this position, annually, and upon termination of employment. To determine how this position is affected, applicants are advised to seek additional information during the interview process from the Ethics and Integrity Staff, Division Management Programs at (301) 796-8435 prior to accepting such a position.

Prohibited financial interests restrictions apply: Employees designated as public or confidential filers, and their spouse or minor children, may not hold financial interests in FDA significantly regulated organizations.

Relocation and travel expense reimbursement: No

Bargaining Unit: Yes/3591/NTEU