Duties

• This position(s) is located in the Food and Drug Administration (FDA), Center for Devices and Radiological Heath (CDRH), in Silver Spring, Maryland.
• As an Engineer in CDRH 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.

Requirements

Conditions of Employment

• Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
• 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.
• Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• THIS POSITION IS SUBJECT TO EXECUTIVE ORDER 14043 MANDATING COVID-19 VACCINATION FOR FEDERAL EMPLOYEES. See section titled Next Steps for more Conditions of Employment for this position.

Qualifications

The position of General Engineer falls under the 0801 occupational series. To qualify for this position at grade GS-11/12, you must meet the following:

This announcement is also being advertised as a GS-13 under announcement number FDA-CDRH-22-DH-11323193SH.

Basic Requirements
You must meet the basic education requirements for this position.

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.

AND

Minimum Qualifications

Specialized experience is experience that equipped the applicant with the particular 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.

For the GS-11:
You must have one year (52 weeks) of specialized experience equivalent to the GS-09 grade level in the Federal service preparing, presenting, and/or defending findings on scientific research; providing consultation to industry, academic and/or private laboratory scientists; and reviewing scientific data and determine project technical needs.

OR

3 years of progressively higher level graduate education leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree.

For the GS-12:
You must have one year (52 weeks) of specialized experience equivalent to the GS-11 grade level in the Federal service that includes evaluating the accuracy, precision, and/or reliability of products such as medical devices and/or radiological products; and collaborating with other scientists, engineers, and/or healthcare professionals within an organization/agency on a wide range of scientific and regulatory issues.

All qualification requirements must be met by 11:59 pm (Eastern Time) on 01/24/2022. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities. You must continue to meet all requirements through the hiring process.

You may be asked to provide additional information at a later time. All interview requests and selection decisions are at the full discretion of the hiring office.

NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date . To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login , select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process.

IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume.

Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.

Education

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

If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. 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. For further information, click on foreign education .

Submitting Your Transcripts: Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript 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 only receive consideration and credit for the information we can access.

See the Application Manager Documentation for tips on submitting your paper-based documents.

Additional information

For some advertisements, the Food & Drug Administration receives hundreds, even thousands, of applications from job-seekers. Because of this high level of interest in positions with the FDA, the agency reserves the option of setting an application number limit.

When an application limit is set, USAJOBS will close the vacancy at 11:59 pm Eastern Time on either :
(A) the day the limit is reached,
-OR-
(B) the pre-defined closing date of 01/24/2022, whichever comes first.

If the limit is reached before 11:59 pm ET, all applications in excess of the limit will continue to be accepted until 11:59 pm ET.

The application limit for this advertisement is: 100

Additional Conditions of Employment:

• Pre-employment physical required: No
• Drug testing required: No
• License required: No
• Mobility agreement required: No
• Immunization required: Yes
• Bargaining Unit Position: Yes -3591
Telework eligible position: Telework is at the discretion of the supervisor.
• Financial disclosure statement, OGE-450, required: Please be advised that this position may be subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position.

For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics .

Additional Information:

• Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
• Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS.
• If you are serving, or have served in the last 5 years (from 01/24/2022) 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 Political Appointee FAQ - OPM for more.

All requirements must be met by the closing date of this announcement (01/24/2022); only education and experience gained by this date will be considered.