Duties

• As an Engineer in CDRH you are responsible for obtaining and reviewing technical literature or data to determine the safety, efficacy, and degree of risk of medical devices to the public health;
• Participates in the interpretation and review of scientific data to determine its validity and scientific significance;
• Assists in the review of technical data submitted with respect to accuracy, precision, and reliability and renders scientific decisions;
• Assists the senior scientists in editing and correcting memorandum, scientific report and other technical documents;
• Assists in responding to inquiries and Freedom-of-Information requests regarding medical devices; and
• Conducts literature searches for senior scientists/reviewers and prepares summaries.

Requirements

Conditions of Employment

• U.S. Citizenship or Permanent Resident is required for this appointment.
• Selective Service Registration: All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Visit www.SSS.gov for more info.
• 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.
• 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.
• You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.
• 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.
• 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.
• Must possess a cumulative GPA of 2.8 on the unweighted 4.0 scale upon completion of your academic degree or certificate program.
• Must sign FDA Pathways Program Participant Agreement.
• Must serve one-year trial period or the duration of the program.
• Pre-employment physical required: No
• License required: No
• Annual leave for non-federal service authorized: No
• Mobility Agreement required: No
• Bargaining Unit Position: Yes
• 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

Applicants must meet the following eligibility requirements to participate in this Recent Graduate Program:

A. Completed all requirements for an associates, bachelors, masters, professional, doctorate, vocational, or technical degree or qualifying certificate with a cumulative GPA of 2.8 or above from an accredited educational institution within the 2 years preceding the closing date of this announcement. -OR-
B. Released or discharged from active duty within the previous two years by 01/31/2022, where as a veteran who, due to a military service obligation, was precluded from applying to the Recent Graduate Program during any portion of the 2-year eligibility period following completion of degree or certificate requirements with a cumulative GPA of 2.8 or above, are entitled to a full 2-year period of eligibility upon release or discharge from active duty. In no event, however, may the eligibility period extend beyond 6 years from the date on which the preference eligible veteran completed the requirements of the degree or certificate. -OR-
C. Individuals that are scheduled to complete a qualifying Associate's, Bachelor's, Master's, Doctorate, professional, vocational or technical degree or certificate program within 9 months from the closing date of this announcement. The degree/certificate must be conferred by 10-30-2022 with a cumulative GPA of 2.8 or above.

NOTE: You must submit transcripts or official documentation to verify your eligibility under the Recent Graduate Program. Transcripts MUST reflect the degree/certificate program and the degree conferred date. If your degree/certificate has not been conferred, you must provide proof of the anticipated graduation date. Selectee's entry on duty date will be upon degree conferment.

In addition to the eligibility requirements for the Pathways Recent Graduate Program, you must also meet the following Individual Occupational Requirements by 10-30-2022 in order to qualify for the Interdisciplinary Engineer, 0801/0830/0850/0858 positions.
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.)
In addition to meeting the Individual Occupational Requirements above, you must also meet the OPM Qualification Requirements listed below by 01/31/2022 in order to qualify for the Interdisciplinary Engineer, 0801/0830/0850/0858, at GS - 7/9.
For GS-7:
A. Applicants must have at least one full year of specialized experience, equivalent to at least the GS-05 level in the Federal service which includes performing literature reviews to gather information used for regulatory or scientific purposes; conducting analyses of scientific data; and preparing reports or presentations related to the results of scientific tests or studies. -OR-
B. Completion of one year of graduate level education related to the position being filled (Engineer) from an accredited college and/or university.-OR-
C. A bachelor's degree as described in the Basic Qualification Requirements above AND meet Superior Academic Achievement provision (S.A.A.) criteria (visit the site for more detail information). S.A.A. is based on (1) class standing, (2) grade-point average, or (3) honor society membership. -OR-
D. Have a combination of experience as described in "A" above and education as described in "B" above, that when combined equals 100% of the total requirements.-OR-
E. Have an engineering bachelor's degree AND have appropriate specialized experience as an Engineering Technician;-OR-
F. Have successfully completed a 5-year program of study of at least 160 semester hours leading to a bachelor's degree in engineering.
For GS-9:
A. Applicants must have at least one full year of specialized experience, equivalent to the GS-07 grade level in the Federal service which includes performing literature reviews to gather information used for regulatory or scientific purposes; reviewing and evaluating scientific data to determine accuracy and completeness; and preparing reports or presentations related to the results of scientific tests or studies.;-OR-
B. Have 2 years of years of progressively higher level graduate education leading to a master's degree in Engineering or master's or equivalent graduate degree;-OR-
C. Have a combination of superior academic achievement AND one (1) year of appropriate specialized Engineering experience;-OR-
D. Have successfully completed a 5-year program of study of at least 160 semester hours leading to a bachelor's degree in engineering AND have one (1) year of appropriate professional Engineering experience.

For more information, please visit the requirements for All Professional Engineering Positions. :

Education

Note: One year of full-time graduate education is considered to be the number of credit hours that the school you attended has determined to represent one year of study. If this information cannot be obtained from your school, we will consider 18 semester/27 quarter hours to be equal to one year of full-time study. This position requires a degree or completion of specific courses in order to meet the basic education requirement. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. Your transcript(s) must clearly demonstrate the course(s) listed in the Basic Qualification requirement section. If the transcript(s) does not clearly demonstrate this, you must submit a copy of the course description and/or other documentation demonstrating that the courses are equivalent. Degree requirements must be met by the closing date of this job announcement and your transcript(s) submitted must reflect this.

EDUCATION STATEMENT - Individual Occupational Requirement: This position has an education requirement. You must submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades) to document that you have met the education requirement. Unofficial transcripts will be accepted in the application package; however, official transcripts will be required prior to beginning employment. Most colleges and universities offer unofficial transcripts online - please check your school website to obtain a copy quickly.

FOREIGN EDUCATION
Applicants using part, or all of their education completed outside of the U.S. to meet the qualification requirements, must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U.S. We will only accept the completed foreign credential 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. Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.

Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below:

National Association of Credential Evaluation Services (NACES)

Association of International Credentials Evaluators (AICE)

Credential evaluations are not free, and applicants are responsible for the cost of the selected service.
For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation

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 receive consideration and credit for the information we can access.

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

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.

Additional information

More information on the Pathways Programs for Recent Graduates can be found at: https://www.opm.gov/policy-data-oversight/hiring-information/students-recent-graduates/

The Pathways Recent Graduates may be non-competitively converted to a term, career-conditional, or career appointment following successful completion of at least one year of continuous service, demonstrated successful job performance, and after meeting all other qualification requirements in accordance with 5 CFR 362.305. To be eligible for conversion to a permanent or term position, Recent Graduates must:

• Successfully completed at least 1-year of continuous service in addition to all requirements of the Program.
• Demonstrate successful job performance.
• Meet the Office of Personnel Management's qualifications for the position to which the Recent Graduate will be converted.
• Recent Graduates are on a trial period for the duration of the program.
• Positions will Require 40 hours of formal training per year.
• Must be a citizen of the United States.

ADDITIONAL CONDITIONS OF EMPLOYMENT:

• If you are serving, or have served in the last 5 years (from 01/31/2022) 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. Political Appointee FAQ - OPM
• 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.
• Veteran's Preference: If you are claiming veterans' preference under competitive procedures, you must submit a copy of your military discharge certificate (DD 214 member 2 or 4 copy), official statement of service from your command if you are currently on active duty, or other proof of eligibility. To be acceptable, the document must show character of service. If you are claiming 10-point veterans' preference, you must also submit an Application for 10-Point Veterans' Preference (SF-15) and the required documentation specified on the reverse of the SF 15. Preference will be granted based on the documents received. S ee Veterans Preference for more.
• Financial disclosure statement, OGE-450, may be required: Please be advised that this position will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers.