Duties

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.

Learn more about this agency

Responsibilities

• 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.

Travel Required

Not required

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.
• 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
• 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 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 06/18/2021, 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 03-17-2022 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 03-17-2022 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 06/18/2021 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.

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 .

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.

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.

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

We may make additional selections for similar positions across the entire Department of Health and Human Services (HHS) within the local commuting area(s) identified in this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s) at HHS. There is no option to opt-out as your information will not be shared with other hiring agencies outside of HHS.

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 06/18/2021) 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.

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 06/18/2021), 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. Technical Knowledge
2. Written Communication
3. Oral Communication

To preview the application assessment questions, click the link below:
https://apply.usastaffing.gov/ViewQuestionnaire/11119094

Background checks and security clearance

Security clearance
Not Required

Drug test required
No

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 except the documents listed above under the "Required Documents:

• Cover Letter
• DD-214/ Statement of Service
• Disability Letter (VA)
• Other supporting documentation not listed above
• 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). If your degree/certificate has not been conferred, you must provide the transcript and proof of the anticipated graduation date. Selectee's entry on duty date will be upon degree conferment.

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 .

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.