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    Duties

    Summary

    This position is located in the Department of Health and Human (HHS), Food and Drug Administration (FDA), Center for Radiological Health (CDRH), Office of Surveillance and Biometrics (OSB), Clinical Outreach Branch I and Clinical Outreach Branch II located in Silver Spring, Maryland.

    Learn more about this agency

    Responsibilities

    • Serve as the Interdisciplinary Engineer within the Division of Patient Safety Partnerships (DPSP) for the evaluation of postmarket adverse event reports concerning medical devices and radiologic products;
    • Perform duties that include resolving a broad range of scientific multidisciplinary issues concerning the application of FDA?s legislated regulatory authorities related to the overall Medical Product Safety Network (MedSun) program;
    • Deviate from or extend traditional methodologies and develop solutions to complex problems, setting precedents that affect internal and industry program activities and regulated materials, machines, devices, or facilities;
    • Analyze and evaluate the implementation of new policies that impact the DPSP's mission and immediately contact the SMEs about the possibility of chances in MedSun program.
    • Responsible for ensuring that the organization?s strategic plan, mission, vision and values are communicated and integrated into the team?s strategies, goals, objectives, and work; communicates to the team milestones;
    • Participate in meetings with the Branch Chief, Division Director and other Center officials, and when appropriate, the Agency, on problems related to products under review;
    • Conduct expert technical review of precedent-setting professional studies, reach, and analysis in scientific and engineering fields and applies findings in the development of national guidance, policies or directives.

    Travel Required

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

    Supervisory status

    No

    Promotion Potential

    14

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    Requirements

    Conditions Of Employment

    • Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
    • 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.
    • Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.
    • 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.
    • Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities.

    Qualifications

    The position of Lead Interdisciplinary Engineer falls under the 0801/0850/0858 occupational series. To qualify for this position at grade GS-14, you must meet Time-in-Grade requirements by 11:59 pm EST on 04/04/2019.

    BASIC QUALIFICATION 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.
    -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
    For more information about EI and EIT registration requirements, please visit the National Society of Professional Engineers website at: http://www.nspe.org.
    The FE examination is not administered by the U. S. Office of Personnel Management. For more information, please visit: http://www.nspe.org/Licensure/HowtoGetLicensed/index.html.
    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.)


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

    For more specifics, please see the OPM qualifications standard for GS-800: All Professional Engineering Positions qualifications at https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0800/files/all-professional-engineering-positions-0800.pdf
    -AND-

    MINIMUM QUALIFICATION REQUIREMENTS, GS-0801-0850-0858-14

    You must have one (1) year of specialized experience that is equivalent to at least the GS-13 grade level in the Federal Service which included analyzing consumer information reports or literature related to deficiencies in the manufacturing and safety of medical devices and/or radiological products in order to determine the source of the defect and impact on current and future public health; and overseeing and evaluating team project activities and delivering presentations to management, staff, or external groups on technical or scientific subject matter.

    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.

    If you are applying based on some other qualifying eligibility (i.e. you are not applying as a current Federal employee), you must meet the specific requirements of the eligibility you are claiming, and must have sufficient past experience to demonstrate that you are minimally qualified for this position. See Unique Hiring Paths on USAJOBS for more information about various ways you may be eligible to apply!

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

    You must submit supporting documentation to verify your eligibility to apply for this vacancy. For most applicants, an SF-50 will be required. However, if you are applying as a Veteran, individual with a qualifying disability, or a displaced employee, you will be required to provide other supporting documents as applicable. See the Required Documents section for more details.

    Education

    Foreign Education:
    If you are using education completed at foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program.
    If you have transferred educational credit from a foreign institution to one in the U.S., you must still show that your foreign education was evaluated by an organization recognized by the Department of Education, even if that foreign education was accepted as transfer credit by a domestic college or university.
    For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.

    Additional information

    ADDITIONAL CONDITIONS OF EMPLOYMENT:

    • Pre-employment physical required: No
    • Drug testing required: No
    • License required: No
    • Mobility agreement required: No
    • Immunization required: No
    • Bargaining Unit Position: No
    • 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.
    • If you are serving, or have served in the last 5 years (from 04/04/2019) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. Political Appointees FAQ - OPM
    • Veterans Preference: If you plan to apply based on Veterans Preference, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. USAJOBS Veterans Site.
    • Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. USAJOBS Individuals with Disabilities Site.
    • Career Transition Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. USAJOBS Career Transtion SIte.
    • Financial disclosure statement, OGE-450, required: 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.
    All requirements must be met by the closing date of this announcement (04/04/2019); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.

    How You Will Be Evaluated

    Once the job opportunity announcement closes (at 11:59 pm ET on 04/04/2019), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether you are qualified for this particular position.
    If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible, or your score may be adjusted to more accurately reflect your skills and abilities. Additionally, we will review your supporting documents and resume to determine if you are in the "Area of Consideration" for this vacancy. Government-Wide Merit Promotion vacancies may only accept applications from a limited audience, pay careful attention to the "Who May Apply" and the "Hiring Paths" information.
    Please follow all instructions carefully. Errors or omissions may affect your eligibility.

    Basis of Rating: Merit Promotion Procedures for the Food and Drug Administration (FDA) 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 ranked into one of two categories: Best Qualified or Qualified.

    Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of these competencies.

    1. Technical Competence
    2. Problem Solving
    3. Organizational Awareness
    4. Leadership
    5. Oral Communication
    6. Writing
    To preview the application questionnaire, click the link below.
    https://apply.usastaffing.gov/ViewQuestionnaire/10439790

    Background checks and security clearance

    Security clearance

    Other

    Drug test required

    No

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    Required Documents

    These documents will be required for ALL applicants:

    • Resume
    • Transcript

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

    These documents may be required for some applicants:
    • Cover Letter
    • DD-214
    • OF-306
    • Licensure, Certification, etc.
    • VA Letter, etc.
    • Resume
    • SF-15
    • SF-50
    • 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:
    If a position lists a positive education requirement (found in the Qualifications or Education sections), you must submit a transcript so we can verify that you meet these requirements. Current employees and anyone who has held this series/grade ARE NOT exempt from the transcript requirement and must still submit transcripts, if required by the position.

    RESUME REQUIREMENTS:
    If you have not written a federal resume before, please watch the Resume Writing Tutorial or read the Resume Writing FAQ. An academic CV (curriculum vitae) may not contain enough information to properly evaluate your work experience!

    CURRENT & FORMER FEDERAL EMPLOYEES:
    You will need to submit a copy of your most recent SF-50 (Standard Form 50 - Notice of Personnel Action) to verify your eligibility status.
    Your SF-50 must show the following information:
    1. Full position title;
    2. Appointment type;
    3. Occupational series;
    4. Pay plan, series, grade, and step;
    5. Tenure code; and
    6. Service Computation Date (SCD).
    If your most recent SF-50 is from an annual pay adjustment, please ensure it contains the information listed above. If it does not, then you should also include your most recent SF-50 that does show your last promotion, execution of appointment, or grade / step increase.
    Learn more about the SF-50 on the USAJOBS SF-50 Help Page.

    VETERANS PREFERENCE:
    You must submit a DD-214 form (Certificate of Release or Discharge) 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.
    Individuals with Disabilities (Schedule A):
    Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities, may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required. Learn more on the USAJOBS Individuals with Disabilities Site.

    Displaced Federal employees who qualify for CTAP/ICTAP:
    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. Learn more on the USAJOBS Career Transition Assistance Site.

    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

    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.
    When an application limit is set, USAJOBS will close the vacancy at 11:59 pm Eastern Time on either:
    (A) the day the limit is reached, -OR-
    (B) the pre-defined closing date of 04/04/2019, whichever comes first.
    If the limit is reached before 11:59 pm ET, all applications in excess of the limit will continue to be accepted until 11:59 pm ET.
    The application limit for this advertisement, if applicable, is: No Limit
    For more information about announcement closing, see: https://www.usajobs.gov/Help/faq/job-announcement/expiration/
    To apply for positions with the Food & Drug Administration, you must have a USAJOBS Login.GOV account, and be signed in to that account, before you click "Apply Online". See the USAJOBS Help Site article "How does the application process work?" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 04/04/2019 We recommend that you start the application process early enough that you can complete and submit your application before this deadline.
    Please note that you cannot submit documentation or make changes to your application after the close date.

    If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: https://www.usajobs.gov/Help/how-to/. Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: https://www.usajobs.gov/Help/. FDA's Applicant Help Desk is not able to support USAJOBS-related issues.

    The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or encounter any difficulty with the site, we recommend that you review the Applicant HELP Site at: https://help.usastaffing.gov/Apply/index.php?title=Applicant. This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you!

    You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis.

    If after reviewing the USAJOBS and Application Manager help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 888-478-4340, or e-mail QuickQuestions@fda.gov.
    The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays.
    If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 10439790 so that we may assist you faster.

    Agency contact information

    FDA Applicant Help Desk

    Address

    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! HHS 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.

    Federal employees with career or career-conditional appointments in the competitive service; former Federal employees with reinstatement eligibility based on previous career or career-conditional appointments; displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) and the Interagency Career Transition Assistance Plan (ICTAP); veterans eligible under provisions of VEOA who are preference eligibles or who have been separated under honorable conditions after 3 years or more of continuous active service; Military Spouses; PHS Commissioned Corps Officers; individuals eligible for VRA appointments (at the GS-11 and below grade levels); and individuals with disabilities.

    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/WhatWeDo/default.htm/

    Next steps

    Once your application is submitted 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. We strive to make selections within 45 days of the closing date of this announcement.
    You will receive application status updates by email and on USAJOBS as the process unfolds.
    How to check your application status via USAJOBS and understand what each status means.
    How does the Hiring Process Work?

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/528269600. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.