This position is with the Food and Drug Administration and is located in the Center for Devices and Radiological Health. CDRH provides consumers, patients and their caregivers with accessible science-based information about the products we oversee. The Center 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.
As a General Engineer, you will be responsible for:
The evaluation of device safety, failure, and/or unsatisfactory performance or design limitations using knowledge of scientific and/or principles and performance parameters.
Presenting data to the agency as well as to external institutions and by organizing and participating in center work groups related to scientific issues, device issues, or guidance and policy development.
Conduct reviews of manufacturers? pre-market submissions of medical devices in conjunction with product evaluation, guidance development, standard setting, and educational activities.
Develop new concepts, hypotheses, and interpretations.
Prepare written evaluations and justifications to support analytical findings of scientific data.
Interact with internal and external experts to identify, develop, and disseminate state-of- the-art and consensus practices for the evaluation of medical devices.
25% or less - You may be expected to travel at 25% or less for this position.
Job family (Series)
0801 General Engineering
Engineers, All Other
Conditions of Employment
Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action
The position of General Engineer falls under the 0801 occupational series. To qualify for this position at grade GS-14, you must meet the following:
In accordance with Executive Order 14043, Federal employees are required to be fully vaccinated against COVID-19 regardless of the employee's duty location or work arrangement (e.g., telework, remote work, etc.), subject to exceptions that may be required by law. If selected, you will be required to submit proof of vaccination by November 22, 2021 or before your entrance on duty if you are selected after the compliance date. Your HR Consultant will provide a list of documents acceptable as proof of vaccination and instructions for how to submit a request for a legally required exception, if needed, to comply with vaccinationrequirement.
Due to COVID-19, the agency is currently in a maximum telework posture. If selected, you may be expected to telework upon your appointment. As employees are permitted to return to the office, you may be required to report to the duty station listed on this announcement within 30 calendar days of receiving notice to do so, even if your home/temporary telework site is located outside the local commuting area. Your position may be eligible for workplace flexibilities which may include remote work or telework options, and/or flexible work scheduling. These flexibilities may be requested in accordance with the HHS Workplace Flexibilities policy.
Basic Requirements: 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.
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.
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 Qualification Requirements candidates must also meet:
Specialized Experience: Specialized experience is experience that equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled.
For the GS-14 level, you must possess one year of experience, equivalent to at least the GS-13 level in the Federal service, experience includes: Analyze and interpret scientific documents, data sets, technical information, and/or opinions related to medical device products; and Evaluate the accuracy and/or reliability of products such as medical devices and/or radiological products. Demonstrate technical knowledge and contributions to the regulatory review and support. NOTE: This information must be supported in your resume to be considered for the position.
All qualification requirements must be met by 11:59 pm (Eastern Time) on 10/29/2021
If after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities. You must continue to meet all requirements through the hiring process.
NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process.
IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification.
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.
If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program. For further information, click on foreign education.
Submitting Your Transcripts: Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.
NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may only receive consideration and credit for the information we can access.
For some advertisements, the Food & Drug Administration receives hundreds, even thousands, of applications from job-seekers. Because of this high level of interest in positions with the FDA, the agency reserves the option of setting an application number limit.
For more information about announcement closing, see: https://www.usajobs.gov/Help/faq/job-announcement/expiration/
Additional Conditions of Employment:
Pre-employment physical required: No
Drug testing required: No
License required: No
Mobility agreement required: No
Immunization required: Yes
Bargaining Unit Position: Yes, 3591
Telework eligible position: Telework is at the discretion of the supervisor.
Financial disclosure statement, OGE-450, required: Please be advised that this position may be subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position.
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.
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.
You may be asked to provide additional information at a later time. All interview requests and selection decisions are at the full discretion of the hiring office.
Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS.
If you are serving, or have served in the last 5 years (from 10/29/2021) 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. See Political Appointee FAQ - OPM for more.
How You Will Be Evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
This is a direct hire announcement. Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy. We will evaluate you against the basic qualifications. Qualified applicants will be referred for consideration in accordance with the Office of Personnel Management direct hire guidelines. Note: Volunteer experience can also be used as qualifying experience.
Interview Process: Structured interviews: may be asked scenario-based interview questions concerning core competencies. Method/tools used to evaluate applicants: work samples, conducting a presentation, reference checks, tests may be used.
Once the job opportunity announcement closes (at 11:59 pm Eastern Time on 10/29/2021), a review of your résumé 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.
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.
Interagency / Career Transition Assistance Program (I/CTAP): Well-Qualified is defined as an applicant who meets the qualification standards and eligibility requirements for the position, including minimum educational and experience requirements; any medical qualifications and suitability; is able to perform the essential duties of the position, with or without reasonable accommodation; meets any applicable selective placement factors for the position (such as the ability to speak a specific language or any other factor required immediately upon hire); and is able to satisfactorily perform the duties of the position upon entry. Learn more on the USAJOBS Career Transition Assistance Site.
Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Background checks and security clearance
Drug test required
Position sensitivity and risk
Noncritical-Sensitive (NCS)/Moderate Risk
Trust determination process
A document that is required must be submitted by all applicants because the document is needed to verify your qualifications, education, or other eligibility information. Failure to provide one of the documents in the list below may result in your application being considered incomplete.
These documents may be required for some applicants. Applicants relying on education to qualify, those seeking consideration under a special hiring authority, or those who need to verify a license or certification, will need to submit appropriate supporting documentation from this list. RESUME REQUIREMENTS:
The federal government has very specific resume requirements. If you have not written a federal resume before, you should 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.
At a minimum your resume should list the position title, employer, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position listed. A CV (curriculum vitae) may not contain enough information to meet these resume requirements.
If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. See the How You Will Be Evaluated section for the agency's definition of well-qualified. Learn more on the USAJOBS Career Transition Assistance Site.
Learn more about supporting documents and documentation requirements on USAJOBS:
How to Understand the Required Documents Section
What Types of Documents May I Need?
How to Manage Your Documents on USAJOBS
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.
A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time, or intermittent. Contact the hiring agency for more information on the specific benefits offered.
This job is open to
Career transition (CTAP, ICTAP, RPL)
Federal employees who meet the definition of a "surplus" or "displaced" employee.
U.S. citizens, nationals or those who owe allegiance to the U.S.
Clarification from the agency
You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This is a direct hire authority announcement. Traditional federal rules regarding rating, ranking, and veterans' preference do not apply. This vacancy will also be used to clear CTAP/ICTAP.