SummaryThis position is located at the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Device Evaluation (ODE) located in Silver Spring, Maryland.
While most positions are expected to be filled in the Office of Device Evaluation, other offices within CDRH may use this announcement to fill positions, as well.
Additional selections may be made within the same geographical area FDA wide.Learn more about this agency
The Interdisciplinary Engineer performs the following duties for the Office of Device Evaluation:
- Reviewing scientific data submitted in support of a variety of medical device submissions (e.g. premarket applications, product development protocols, applications for investigational device exemptions, etc.) to determine its accuracy and sufficiency.
- Reviewing research protocols used to evaluate medical devices and recommending new or modified methods for testing and data analysis.
- Writing and evaluating guidelines concerning data submissions for medical devices and their marketing.
- Making presentation to the medical/scientific panel members on the FDA Advisory Committee responsible for the classification and premarket review of medical devices.
- Drafting a variety of reports and summaries on the safety and effectiveness of devices submitted in a premarket approval application.
Occasional travel - You may be expected to travel for this position.
Conditions of Employment
Conditions of Employment:
- Security and Background Requirements: Appointment will be subject to the applicant's successful completion of a background security investigation. Failure to successfully meet these requirements may be grounds for appropriate personnel action. If hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection and/or appropriate disciplinary action.
- E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.
- Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
- U.S. Citizenship is required
- One-year probationary period may be required.
- Pre-employment physical required: No
- Drug testing required: No
- License required: No
- Mobility agreement required: No
- Registered or exempt from Selective Service as applicable (www.sss.gov)
- 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.
- Bargaining Unit Position: Yes
- All qualification requirements must be met by the date of your application submission.
- Financial disclosure statement required: No
QualificationsThis is an Interdisciplinary announcement and may be filled in one of the following series: 0801 (General Engineer), 0830 (Mechanical Engineer), 0850 (Electrical Engineer), or 0858 (Biomedical Engineer).
PLEASE NOTE: This announcement will be used to establish a standing inventory of applicants ready to be considered for Interdisciplinary Engineer 12/13 positions. Qualified candidates will receive consideration for vacancies as positions become available at CDRH. Qualified candidates will receive consideration for vacancies until selected, or their eligibility expires. For information concerning the period of eligibility, please see the "What To Expect Next" section of this announcement.
In order to be qualified for this position, you must meet the basic requirement in one of the following ways AND minimum qualification requirement as noted below:
A. A bachelor's or higher degree in 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. 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), or licensure as a Professional Engineer (PE) by any State, the District of Columbia, Guam, or Puerto Rico. (You must submit licensure or registration for confirmation under this provision.)
2. Written Test -- You must submit evidence of having successfully passed the Fundamentals of Engineering (FE) 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 under this provision.
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.)
Minimum Qualification Requirement GS-12:
In addition, to be qualified at the GS-12 level, you must possess one full year of specialized experience equivalent to at least the GS-11 grade level in the Federal service performing duties such as:
- Analyzing scientific data submitted by other scientists/researchers in order to provide feedback or recommendations on methods/procedures utilized.
- Assisting in conducting research or briefings on the classification and scientific review of medical device products or other scientific systems/designs.
- Modifying existing guidelines and protocols for scientific testing of medical device products or other scientific systems and designs.
- Providing information and advice to researchers or scientists on guidelines, scientific, or regulatory requirements related to research on scientific products.
Minimum Qualification Requirement GS-13:
In addition, to be qualified at the GS-13 level, you must possess one full year of specialized experience equivalent to at least the GS-12 grade level in the Federal service performing duties such as:
- Reviewing technical or complex engineering data (e.g. related to multi-step processes, combination products, etc.) in order to determine the accuracy, safety, or effectiveness of a medical device or radiological product.
- Reviewing research protocols to evaluate medical device products or radiological products.
- Recommending solutions to scientific complaints, research discrepancies, and/or product problems related to medical devices or radiological products.
- Providing advice and assistance to scientists in developing scientific and technical policies.
(This experience must be clearly demonstrated in your resume).
IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE MAY NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. If your resume does not support your questionnaire answers, we will not allow credit for your response(s).
NOTE: 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; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to gain employment. You will receive credit for all qualifying experience, including volunteer experience. If such experience is on a part-time basis, you must provide the average number of hours worked per week as well as the beginning and ending dates of the experience so it can be fully credited.
All qualification requirements must be met by the date of your application submission.
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. Your transcript(s) must clearly demonstrate the course(s) listed in the 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.
Special Instructions for Foreign Education: 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; or full credit has been given for the courses at a U.S. accredited college or university. Failure to provide such documentation with your application will result in lost consideration. For further information, visit: https://sites.ed.gov/international/recognition-of-foreign-qualifications/.
Veterans' Preference: If you are a veteran with preference eligibility and you are claiming 5-point veterans' preference, you must submit a copy of your DD-214 (Member Copy 4) or an official statement from your command if currently on active duty that certifies you are 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 signed. If you are claiming 10-point veterans' preference, in addition to the DD-214, you must also submit a Standard Form 15 (Application for 10-Point Veteran Preference) and the required supporting documents listed on that form. For more information on veterans' preference see http://www.fedshirevets.gov/.
Political Appointment: If you are serving, or have served in the last 5 years (from the close of this announcement) 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 questionnaire and certify your responses.
Career Transition Program: This program applies to Federal service employees whose positions have been deemed surplus or no longer needed, or employees who have been involuntarily separated from a Federal service position within the competitive service. To receive selection priority for this position, you must: 1) meet eligibility criteria for CTAP or ICTAP; 2) be rated well-qualified for the position; and 3) submit the appropriate documentation to support your CTAP or ICTAP eligibility. Well-Qualified includes those applicants whose knowledge, skills, and abilities clearly exceed the minimum qualification requirements for the position. For information on eligibility criteria and required documentation, go to: http://www.opm.gov/rif/employee_guides/career_transition.asp
Selective Service: Males born after 12/31/59 must be registered or exempt from Selective Service (see http://www.sss.gov/).
Reasonable Accommodation: This agency provides reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please see Agency Contact Info for whom to contact for more info. The decision on granting reasonable accommodation will be made on a case-by-case basis. For information on disability employment, please visit https://www.opm.gov/policy-data-oversight/disability-employment/
You are encouraged to apply online. If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application.
How You Will Be Evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
Once the application process is complete, a review of your resume and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job.
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.
Basis of Rating: Category rating procedures will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be assigned to one of the following quality categories:
- Best Qualified- Applicants who have experience that is almost identical to those required by the position.
- Well Qualified- Applicants who have experience that is very similar to those required by the position.
- Qualified- Applicants who meet minimum qualification requirements, but do not identify any additional qualifying experience or skill.
The Category Rating Process does not add veteran's preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher). Veteran preference eligibles will receive selection consideration before non-preference eligibles within each quality category.
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.
- Oral Communication
- Problem Solving
- Technical Competence
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.
To preview the assessment questionnaire, click the following link: https://apply.usastaffing.gov/ViewQuestionnaire/10311708
Background checks and security clearance
Drug test required
- Your Résumé - You are encouraged to use the USAJobs online resume builder to ensure that all required information is in your resume. If you use your own résumé, curriculum vitae, or any other written form you choose, you must provide a detailed description of your job-related qualifications that includes beginning and ending dates with the month and year and hours worked per week (if less than 40) for each paid and non-paid work experience job title listed. Full-time employment will be assumed unless otherwise stated on your resume. Part-time employment will be prorated in crediting experience. Not providing this information may result in the lowering of your assessment score or an ineligible rating. For resume writing guidance, please visit the USAJobs Resource Center or view their video tutorial.
- Responses to the Assessment Questionnaire (https://apply.usastaffing.gov/ViewQuestionnaire/10311708)
- College transcripts
- Cover letter
- Discharged Veterans: If you are claiming 5 point preference, you must submit a copy of your DD Form 214, Certificate of Release or Discharge from the armed forces that supports dates of service and discharge status; if claiming 10 point preference, an application for 10-Point Veterans Preference (SF-15) and an official document dated 1991 or later, from the Department of Veterans Affairs or from a branch of the Armed Forces, and/or any other associated documentation based on your preference.
- Active Duty Members: Under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011, if claiming 5 point preference, 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.
- CTAP/ICTAP documentation:
- A copy of your RIF separation notice, notice of proposed removal for failure to relocate, notice of disability annuity termination, or certification from the National Guard Bureau or Military Department that you are eligible for disability retirement;
- A copy of your SF-50 "Notification of Personnel Action'', documenting your RIF separation, noting your positions, grade level, and duty location, and/or Agency certification of inability to place you through RPL, etc.;
- A copy of your latest performance appraisal including your rating; and
- Any documentation from your agency that shows your current promotion potential.
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. Learn 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.
How to Apply
To apply for this position, you must complete the occupational questionnaire and submit the documentation specified in the Required Documents section below.
To receive consideration for this position, you must submit a complete application (including all Required Documents) by 11:59 PM (ET) on the closing date of this announcement, which is 09/30/2019.
Instructions for applying to this job:
- To begin, click Apply. You must be logged into your USAJOBS account to apply. If you do not have a USAJOBS account, you will need to create one before beginning the application.
- After logging into your USAJOBS account, you will be taken to an online application which you must complete in order to apply for the position. *Verify the documents required for your application. Follow the prompts to select your USAJOBS resume and/or other supporting documents. You will have the opportunity to upload additional documents to include in your application.
- Complete the online questionnaire, include necessary supporting documents and submit your application using the Submit Application button. Your application package will not be processed unless you click Submit Application.
- To verify the status of your application, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and select the More Information link for this position. The Application Status page will display the status of your application, the documentation received and processed, and your responses submitted to the online application. Your uploaded documents may take several hours to clear the virus scan process.
- To return to saved application at a later date, 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.
By submitting your application, you are certifying the accuracy of the information contained in your application. If you make a false statement in any part of your application, you may not be hired; you may be terminated after you begin work; or, you may be fined or jailed. After making a tentative job offer, we will conduct a suitability/security background investigation.
Agency contact information
Mid-Atlantic Services Branch
AddressCenter for Devices and Radiological Health
10903 New Hampshire Ave
Silver Spring, MD 20993
Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview as positions become available. As this process is completed, referred candidates will receive notification via e-mail.
PERIOD OF EMPLOYMENT CONSIDERATION: Qualified applicants will receive employment consideration for a period of three months from the date their name is entered on the inventory (date of most recent application). Applicants who would like consideration beyond the three-month eligibility period MUST reapply once their eligibility period has expired.
You will be required to submit official documentation prior to appointment. The agency will then verify the information provided on your application (i.e., degree, veterans' preference, disability, etc.).
Fair & Transparent
The Federal hiring process is setup to be fair and transparent. Please read the following guidance.
Equal Employment Opportunity Policy
The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.
Reasonable Accommodation Policy
Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis.
A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits.
Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when:
- An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.
- An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.
- An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events.
You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis.
Legal and regulatory guidance
This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/511682900. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.