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General Engineer

Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, Office of Product Evaluation and Quality
This job announcement has closed

Summary

The Center for Devices and Radiological Health (CDRH) assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

Overview

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Hiring complete
Open date: 03/30/2022
Closed date: 04/12/2022
Location
Many vacancies in the following location:
Work site options
Telework eligible
Yes—as determined by the agency policy.
Relocation expenses reimbursed
No
Salary
$38,503 - $61,227 per year

The salary listed in the vacancy announcement is at the base level. The geographical locality pay will be determined at the time of selection.

Pay scale & grade
GS 7 - 9
Promotion potential
13
Pay scale and grade determines the salary of the job.
Work schedule
Full-time
Travel Required
25% or less - You may be expected to travel for this position.
Appointment type
Recent Graduates
Occupations and job series
Supervisory status
No
Federal service type
This job is in the Excepted Service
Drug test
No
Security clearance
Other
Position sensitivity and risk
High Risk (HR)
Jobs require a background check and some require a security clearance. The type depends on the job.
Background check type
Announcement number
FDA-CDRH-22-RG-11435218-WW
Control number
644168200

This job is open to

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Clarification from the agency

Recent graduates who have completed a qualifying associates, bachelors, masters, professional, doctorate, vocational or technical degree or certificate from a qualifying educational institution within the previous two years; veterans unable to apply within two years of receiving their degree, due to military service obligation, have as much as six years after degree completion to apply; or students expecting to obtain a degree or certificate up to 9 months from the closing date may apply.

Duties

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  • 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 memoranda, scientific report and other technical documents.
  • Participates in scientific meetings related to research or scientific investigations.

Requirements

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Conditions of employment

  • U.S. Citizenship or nationals.
  • 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.
  • Overall GPA of at least 3.0 or better.
  • Must sign FDA Pathways Program Participant Agreement.
  • Must serve one year trial period or the duration of the program.

Qualifications

The Office of Product Evaluation and Quality (OPEQ) is recruiting for the Total Product Life Cycle (TPLC) Fellowship Program. This is a two (2) year rotation program that will provide opportunities to learn about various medical devices and the regulatory review process. If you are a recent graduate, want to learn about the regulatory process, and gain regulatory experience this is a great opportunity to join the TPLC Fellowship Program. Upon completion of the program, participants will be placed within OPEQ to conduct TPLC review of medical devices.

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 at least 3.0 overall GPA 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 04/12/2022, 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 3.0 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 01-11-2023 with a cumulative GPA of 3.0 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 in order to qualify for the General Engineer, 0801 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 04/12/2022 in order to qualify for the General Engineer, GS-801- 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 interpreting or reviewing scientific data. -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 preparing scientific progress reports, presentations or conducting analysis.-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.

Education

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

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:

  1. National Association of Credential Evaluation Services (NACES)
  2. 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.

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 04/12/2022) 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.
  • Financial disclosure statement, OGE-450: This position may require financial disclosure reporting and 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. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.
  • Pre-employment physical required: No
  • Drug testing required: No
  • License required: No
  • Mobility agreement required: No
  • Immunization required: No
  • Annual leave for non-federal service authorized: No
  • Bargaining Unit Position: Yes

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

Once the job opportunity announcement closes (at 11:59 pm Eastern Time on 04/12/2022), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether you are qualified for this particular position.

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.

If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration. These assessment methods/tools may also be listed under Key Requirements.

About Category Rating (DEU) Procedures (Basis for Rating):

  • Category rating procedures will be used to rate and rank candidates.
  • The answers you provide to the applicant self-assessment questions will be used, in conjunction with the supporting documents you include, and your resume, to determine your eligibility for Federal employment and your qualification for this position specifically.
  • Your application score is used to place you into one of three quality categories: "Best Qualified", "Well Qualified", and "Qualified". (The category assignment is a measure of the degree in which your background matches the competencies required for this position.)
  • The cut-off score for each quality category may vary from announcement to announcement, and is determined by each agency, in advance of the advertisement going live.
  • Category Rating does not add veterans preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles Vets who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 30% must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).
  • Only applications in the Best Qualified category are referred to the hiring office for consideration.
  • If a high volume of applications are from highly qualified preference eligible Veterans, FDA's HR office may elect to refer ONLY those preference eligible Veterans to the hiring office for consideration.
  • If FDA receives a small number of applications, or if the score range of applications in the highest quality category is low enough, the Best Qualified category may be merged with the Well Qualified category and the merged list may be provided to the hiring office instead.
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.
  1. Technical Knowledge
  2. Written Communication
  3. Oral Communication
To preview the application assessment questions, click the link below:
https://apply.usastaffing.gov/ViewQuestionnaire/11435218

Food and Drug Administration

Become a part of the Department that touches the lives of every American.

At the Department of Health and Human Services (HHS) you can give back to your community, state, and country, by making a difference in the lives of Americans everywhere! HHS is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.


The Food and Drug Administration is the premier scientific regulatory agency responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, as well as publishing accurate, science-based information the public needs in order to use medicines and foods to improve their health.

The Recent Graduate Program is a program that provides employment opportunities for recent graduates and individuals who obtained certificates from qualified educational institutions or programs. The program enables individuals to explore Federal civil service employment at the beginning of their careers; and engages them at the onset of their work lives, before their career path are fully established. The program duration is one year. Upon successful completion of the program and at the agency's discretion, the appointee may be converted to a term or permanent position in the competitive service.

Agency contact information

FDA Applicant Help Desk
Phone
888-478-4340
Email
quickquestions@fda.gov
Address
FDA Center for Devices and Radiological Health
10903 New Hampshire Ave
Silver Spring, MD 20993
US

Visit our careers page

Learn more about what it's like to work at Food and Drug Administration, what the agency does, and about the types of careers this agency offers.

https://www.fda.gov/AboutFDA/WhatWeDo/default.htm

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