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    Duties

    Summary

    This Direct-Hire position is within the Department of Health & Human Services, Food and Drug Administration, with the Center for Devices and Radiological Health in Silver Spring, MD.

    See the sections below for more details on the duties & qualifications for this position.

    Learn more about this agency

    Responsibilities

    • Reviews and evaluates evidence and technical data submitted in support of the medical device submissions with respect to accuracy, precision, and reliability.
    • Maintains records, interprets results, and prepares summary reports of investigation including tables and graphs.
    • Designs and conducts experimental and theoretical studies to evaluate the performance of medical devices and radiological products.
    • Develops, modifies, and evaluates guidelines concerning data required in device actions submitted to the Agency for medical devices.

    Travel Required

    Not required

    Supervisory status

    No

    Promotion Potential

    13

  • Job family (Series)

    1310 Physics

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    Requirements

    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 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.
    • Pre-employment physical required: No
    • Drug testing required: No
    • License required: No,
    • Mobility agreement required: No
    • Immunization required: No
    • Bargaining Unit Position: Yes
    • This is a Direct-Hire advertisement: Veterans Preference is not applicable to this advertisement. Learn more about Direct-Hire at https://www.opm.gov/policy-data-oversight/hiring-information/competitive-hiring/#url=directhire ...
    • Selecting Service Registration: If you were born male, after, December 31st 1959, you must be registered with the Selective Service System, or have an approved exemption. Learn more at www.SSS.gov...

    Qualifications

    BASIC QUALIFICATIONS:
    In order be eligible for the position of Physicist,
    (GS-1310-11/12/13), you must meet the following requirements:

    A: Degree: physics; or related degree that included at least 24 semester hours in physics.

    OR

    B: Combination of education and experience -- courses equivalent to a major in physics totaling at least 24 semester hours, plus appropriate experience or additional education.

    In either A or B above, the courses must have included a fundamental course in general physics and, in addition, courses in any two of the following: electricity and magnetism, heat, light, mechanics, modern physics, and sound.
    MINIMUM QUALIFICATIONS REQUIREMENTS: For further consideration for the Physicist, GS-1310-11/12/13, in addition to the basic education requirement listed above, you must meet the following requirements for each grade level for which you wished to be considered.

    TO QUALIFY FOR THE GS-11
    A. Have one year of specialized experience, equivalent to the GS-9 grade level in the Federal service, developing guidelines applicable to regulations that may include medical devices. Providing consultation to industry, academic, and private laboratory scientists. Review scientific data and determining project technical needs.

    OR

    B. Three years of progressively higher level graduate education leading to a Ph.D. in a related field.

    OR

    C. Have a combination of experience as described in "A" above and graduate education as described in "B" above. When combining education with experience, first determine the applicant's total qualifying education as a percentage of the education required for the grade level; then determine the applicant's experience as a percentage of the experience required for the grade level; finally, add the two percentages. The total percentage must equal at least 100 percent to qualify.

    TO QUALIFY FOR THE GS-12
    Have one year of specialized experience, equivalent to the GS-11 grade level in the Federal service, serving as a technical authority to scientists on problems or technologies related to physics which may include medical devices. Review research protocols to evaluate technologies that may include medical devices. Maintain records, interprets results, and prepares summary reports of investigation including tables and graphs. Interpret conflicting regulations and develops and issues guidance in the form of new policies and regulations.

    TO QUALIFY FOR THE GS-13
    Have one year of specialized experience, equivalent to the GS-12 grade level in the Federal service, developing and evaluating guidelines concerning scientific data; Providing scientific support for regulatory and/or compliance activities which may included medical devices and/or radiological products; Integrating applicable quality management principles and best practices into business processes; Advising on compliance and/or regulatory policy developments and/or implementation of activities which may include but not limited to medical devices and/or radiological products.

    In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description.

    Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.

    PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply through this announcement. Candidates will be referred as Commissioned Corps personnel and not as candidates for conversion to a permanent career or career-conditional appointment.

    All qualification requirements must be met by 11:59 pm (Eastern Time) on 09/13/2019. 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.

    Education

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

    Additional information

    • 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 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.
    • Pre-employment physical required: NO
    • Drug testing required: NO
    • License required: NO
    • Mobility agreement required: NO
    • Immunization required: NO
    • Bargaining Unit Position: YES, 3591
    • Relocation 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.
    • 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
    • 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.
    • Scientific Research Positions: Research positions require an evaluation of the scientific contributions, recognition and professional standing of the researcher as they related to the position being filled.
    • Writing Samples & Portfolios: A writing sample or publication portfolio may be required.
    • Peer Review: Some scientific and research positions may be subject to peer review.
    • Selecting Service Registration: If you were born male, after, December 31st 1959, you must be registered with the Selective Service System, or have an approved exemption. Learn more at www.SSS.gov.

    How You Will Be Evaluated

    Once the job opportunity announcement closes (at 11:59 pm ET on ), your resume and all supporting documents will be reviewed by HR to determine your eligibility for Federal employment and your qualification for this position specifically.

    Because this vacancy will be filled through OPM's Direct Hire Authority. Veterans Preference and traditional rating and ranking of applicants do not apply to positions filled under this announcement. Applications received as a result of job fairs, recruitment events, and emergency hiring mechanisms in support of this hiring initiative will also be accepted during the duration of the direct-hire authority. All qualified candidates will be referred for consideration; the hiring office may conduct interviews at their discretion.

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

    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. Evaluation of Scientific Data
    2. Regulatory Review and Analysis
    3. Planning and Evaluating

    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

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    Required Documents

    The following documents are REQUIRED from all applicants for this vacancy,

    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.

    The following additional documents are ACCEPTED for this vacancy, and may be required for some applicants, depending on what eligibility you are claiming.

    These supplemental documents are ued to support your application claims but may not apply to every applicant. If a document appears in this list, it may still be required for verification purposes, such as claims for special hiring authorities, licensure or certification, education, etc. The links below will provide additional information about documentation.

    Notes about Veterans Preference Documents:
    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.
    Learn more about supporting documents and documentation requirements 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.

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    Benefits

    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.

    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.

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    How to Apply

    To apply for this position, you must complete the assessment questionnaire and submit all documentation specified in the Required Documents section. To receive consideration for this position, you must submit your complete application by 11:59 pm Eastern Time on the closing date of this announcement ().

    Instructions for applying to this job:

    1. You must be signed in to USAJOBS. If you do not have a USAJOBS account, you must first create one before you can apply
    2. If you are signed in, you can tap/click "Apply Online" to begin the process.
    3. USAJOBS will ask you to select a resume to submit. We recommend that you submit a USAJOBS Resume Builder formatted resume so that you know you're submitting all the information we will need. You may also submit a resume in the format of your choice. For tips on what to include in your resume, see the USAJOBS Resume Help site.
    4. USAJOBS will then allow you to include documentation from your USAJOBS Saved Documents area. (You may also attach additional supporting documents during this stage, or you may do so prior to submitting your application.)
    5. You will then be required to respond to certify your application materials and you'll be given the chance to elect to provide demographic information (if you have completed this part of your USAJOBS profile).
    6. Finally, you will be transferred to the USA Staffing® Application Manager system to complete the occupational questionnaire and finalize your application for submission. Follow the on-screen instructions provided and respond to ALL questions presented to you. You will be allowed to finalize and submit additional documents one last time. You will review your application and make final submission. You will then be returned back to USAJOBS.
    7. Should you need help while using the Application Manger site, please click the ? Help icon at the top-right corner of the screen, or see the Applicant Help Site. If this does not resolve your question, the FDA Applicant Help Desk contact information is below.
    Instructions for reviewing or editing your application:
    1. If you need to make a change to your application, or if you just want to know your application status, you will need to be logged in to your USAJOBS account. Tap/click on your name in the top-right corner, then select "Applications".
    2. You will see a list of the most recent applications you have submitted. Tap/click on the one you wish to review or edit. The item will expand and provide your current status, along with additional information about that application. If you wish to change something then tap/click the "Update Application" button.
    3. You will be taken through the same steps you did when you initially applied. You can make changes to add or remove supporting documents before being transferred over to the USA Staffing® Application Manager where you can continue making changes to your responses to the occupational questionnaire. Step through the process as you did the first time, taking care to make the changes you need, and submitting in the final step.
    If you would like to preview the assessment questionnaire you may do so by clicking this link:

    You are encouraged to apply online. Applying online will allow you to review and track the status of your application. 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 contact the FDA Applicant Help Desk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email quickquestions@fda.gov. (If you request by e-mail, please replace the blank space in the body with the Vacancy Identification Number, VIN, which is:). Decisions on granting reasonable accommodation will be made on a case-by-case basis.
    The FDA Applicant Help Desk is staffed from 7am to 6pm (Eastern Time), Monday through Friday, except Federal holidays.

    Agency contact information

    FDA Applicant Help Desk

    Address

    FDA Center for Devices and Radiological Health
    10903 New Hampshire Ave
    Silver Spring, MD 20993
    US
    Learn more about this agency

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

    Visit our careers page

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

    https://www.fda.gov/aboutfda/workingatfda/default.htm/

    Next steps

    Once you have submitted your complete application, (to include the resume, all required supporting documentation, and the responses to the assessment questionnaires), your application will be reviewed by HR to determine your eligibility and qualification status. If you are referred to the hiring office, they may contact you at their discretion for an interview. If you are not referred, you may not immediately receive a notification due to the high volume of applications that are typically submitted to direct-hire advertisements.

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 in the workplace or the way things are customarily done that provides an equal employment opportunity to an individual with a disability. Under the Rehabilitation Act of 1973 the Equal Employment Opportunity Commission (EEOC) must provide reasonable accommodations:

  • 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.

Legal and regulatory guidance

This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/544357100. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.