Duties

Summary

LOCATION: The Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) in Silver Spring, MD.

Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities.
Learn more about this agency

Responsibilities

• Serves either as a general, mechanical, electrical or biomedical engineer, responsible for receiving formal and on-the-job instruction and training designed to provide familiarization and exposure to the full spectrum of functions.
• Provides training and exposure to the full range of procedures and processes required to review and evaluate medical devices.
• Provides assistance to the senior scientific reviewers by reviewing, summarizing, and making preliminary recommendations on a variety of medical device actions
• Performs literature searches, obtains and reviews reference material relating to device safety, efficacy, existing device standards, and material received as a result of calls for industry data in the Federal Register.
• Performs various administrative duties associated with the advisory panel activities. Participates in the interpretation and review of scientific data to determine its validity and scientific significance.
• Coordinates, reviews, researches and prepares responses to Freedom of Information Requests. Assists the senior scientists in editing and correcting memorandum, scientific reports and other technical documents.

Travel Required

Occasional travel - You may be expected to travel for this position.

Supervisory status
No

Promotion Potential
13

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.
• Overall GPA of at least 2.8 or better.
• Must sign FDA Pathways Program Participant Agreement.
• Must serve one year trial period or the duration of the program.
• Pre-employment physical required: No
• Bargaining Unit Position: Yes
• Annual leave for non-federal service authorized: No
• Mobility Agreement required: No
• Immunization required: No

Qualifications

Applicants must meet the following eligibility requirements by 06/24/2019 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 06/24/2019, 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, 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.

NOTE: You must submit transcripts or official documentation, to verify Recent Graduate Program eligibility. Transcripts MUST reflect the degree/certificate program and the degree conferred date.

In addition to the eligibility requirements for the Pathways Recent Graduate Program, you must also meet the following qualification requirements by 06/24/2019 in order to qualify for the Interdisciplinary Engineer, 0801/0830/0850/0858, at GS - 5/7.
Basic Qualification for a Interdisciplinary Engineer, GS-801,803,850,858-5/7:

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 Basic Qualifications Requirement above, you must also meet the Minimum Qualifications Requirement listed below for the GS-5/7:

GS-05: Note: An applicant who meets the basic requirements as specified in A or B above, except as noted under B.1., may qualify for positions in any branch of engineering unless selective factors indicate otherwise.

GS-7:
A. Specialized Experience: Applicants must have at least one full year of specialized experience, equivalent to at least the GS-05 level in the Federal service to include:

• Assist in the review and evaluation of scientific data to determine its completeness or accuracy;
• Perform literature reviews to gather information used for regulatory or scientific purposes;
• Assist scientists or researchers with the administrative aspects of their work; and
• Edit existing reports, memos, presentations, or correspondence 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. S.A.A. is based on (1) class standing, (2) grade-point average, or (3) honor society membership. Class standing -- Applicants must be in the upper third of the graduating class in the college, university, or major subdivision, based on completed courses. Grade-point average (G.P.A.) -- Applicants must have a grade-point average of: 3.0 or higher out of a possible 4.0 ("B" or better) as recorded on their official transcript, or as computed based on 4 years of education, or as computed based on courses completed during the final 2 years of the curriculum; or 3.5 or higher out of a possible 4.0 ("B+" or better) based on the average of the required courses completed in the major field or the required courses in the major field completed during the final 2 years of the curriculum. Grade-point averages are to be rounded to one decimal place. For example, 2.95 will round to 3.0 and 2.94 will round to 2.9. Election to membership in a national scholastic honor society -- Applicants can be considered eligible based on membership in one of the national scholastic honor societies listed below. These honor societies are listed by the Association of College Honor Societies;
-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 more information, please visit the requirements for All Professional Engineering Positions. :

Education

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.

Official Transcript:
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.

Foreign Education:
If you are using education completed at 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.

If you have transferred educational credit from a foreign institution to one in the U.S., you must still show that your foreign education was evaluated by an organization recognized by the Department of Education, even if that foreign education was accepted as transfer credit by a domestic college or university.

For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation .

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.

These are interdisciplinary engineer positions and may be filled in one of the following series:

• GS-0801, General Engineer
• GS-0830, Mechanical Engineer
• GS-0850, Electronics Engineer
• GS-0858, Biomedical Engineer

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 06/24/2019) 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, ma 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..

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 06/24/2019), 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.

Please follow all instructions carefully. Errors or omissions may affect your eligibility.

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. Engineering.
2. Written communication.

3. Oral communication.
To preview the application assessment questions, click the link below:
https://apply.usastaffing.gov/ViewQuestionnaire/10512638

Background checks and security clearance

Security clearance
Not Required

Drug test required
No

Position sensitivity and risk
Non-sensitive (NS)/Low Risk

Trust determination process
Suitability/Fitness

Required Documents

These documents will be required for ALL applicants:

• Resume
• Transcript

If you need instructions or assistance with submitting documentation, please see the Applicant Help Site - Documents page.

These documents may be required for some applicants:

• Cover Letter
• DD-214/ Statement of Service
• OF-306
• Professional License or Certificate, Performance Appraisals, Awards, etc.
• VA Letter or other Veteran-supporting documents
• Resume
• SF-15
• SF-50/ Notification of Personnel Action
• Transcript

Documents in this list are being accepted from all applicants, but may be required for some. If you are unsure what documents might apply to you, please review the USAJOBS FAQ article: " What types of documents might I need to provide? " or contact the FDA Applicant Help Desk.

TRANSCRIPTS:
Transcripts MUST reflect the degree/certificate program and the degree conferred date (Official transcript is required upon selection).
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.

RESUME REQUIREMENTS:
The federal government has very specific resume requirements. If you have not written a federal resume before, you may want to watch this Resume Writing Tutorial video on the USAJOBS YouTube channel , or read through a helpful Resume Writing FAQ on the USAJOBS Help Site to learn what details you should, and should not, include in your resume. A CV (curriculum vitae) may not contain enough information to meet these resume requirements.

DOCUMENTATION REQUIREMENTS WHEN CLAIMING VETERANS PREFERENCE:
Must submit a copy of your DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status.

• Active Duty Members: To claim status Under the VOW (Veterans Opportunity to Work) to hire Heroes Act of 2011, submit written documentation from the armed forces that certifies the service member is expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
• Parents of Deceased or Disabled Veterans: To claim status under Gold Star Fathers Act of 2015, you must submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted.
• Widow or Widower: To claim preference, you must submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted.
• Spouse of a Living Veteran: To claim preference, you must submit a copy of the veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference, and Documentation of Veteran's Inability to Work Because of a Service-Connected Disability. Please follow the instructions in the SF-15 on required documentation to be submitted.

See the Feds Hire Vets site for detailed information about documentation requirements.
USAJOBS also maintains a help page for Veterans .

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.

To return to an incomplete application, log into your USAJOBS account and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete.

If you are relying on your education to meet qualification requirements:

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 .

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.