This Position Is No Longer Available
  1. Overview
  2. Duties
  3. Qualifications & Evaluations
  4. Benefits & Other Info
  5. How to Apply

Job Title:Biomedical Engineer

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-MP-13-758686

This position is closed and no longer accepting online applications through USAJOBS.

The contents of the announcement can still be viewed.


$105,211.00 to $136,771.00 / Per Year


Wednesday, October 03, 2012 to Tuesday, October 16, 2012




Full Time - Permanent




1 vacancy in the following location:
White Oak, MD United StatesView Map


Qualified Current Civil Service Employees


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. 

Who May Apply:  This vacancy is open to current Food and Drug Administration (FDA) employees with competitive status only.  Competitive status refers to employees who are serving on a career or career conditional appointment.


PHS Commissioned Corps Officers currently working for FDA and 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 your SF-50, transcripts (clearly showing courses, degree(s) awarded, and when degree was awarded).  


This position is located in the U.S. Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Surveillance and Biometrics (OSB), Office of the Director (OD).  


Please note that this announcement has been extended to October 16, 2012. 




  • U.S. Citizenship is required.
  • You must submit your SF-50 or Personnel Order (Commissioned Corps).
  • You must submit your transcripts.


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Major Duties:


If selected for this position, you will:


Coordinate with cross-center expert teams with the responsibility of defining, evaluating, refining, and resolving new postmarket safety issues involving complex medical devices.    


Provide recommendations and guidance about medical device safety issues to a variety of audiences, including high level management and the regulated industry.   


Ensure the timely analysis, solution development, and resolution of newly identified postmarket safety issues.


Ensure accountability for the signal management process by overseeing the documentation and tracking of postmarket safety signals. 

    Coordinate the preparation of issues papers, reports, presentations and briefings on emerging postmarket safety issues. 


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        For the GS-858-14 Biomedical Engineer position you must:


        Possess at least one year of specialized experience equivalent to at least the GS-13 grade level in the Federal service.  Examples include significant experience with the following: applying advanced engineering theories, principles, concepts, standards, and methods to provide expert advice to senior colleagues and/or agency officials regarding medical device issues. Work with the application of good clinical practices, human subject protections, clinical research, and recent developments allowing to review and provide recommendations to issues and questions related to the regulated industry and medical devices.  Work that allowed collaborative working relationships with others at different levels within the organization.  Experience presenting findings and recommendations in scientific terms, both verbally and in writing, including identifying and clearly presenting problems, proposals, and making recommendations, providing expert guidance to management and/or other staff at different levels within the organization.  Experience working as an expert with scientific properties, analysis, behavior, and the impact of these properties as it relates to diagnostic tests and safety and effectiveness of medical devices.  Experience with work involving the Federal Food, Drug, and Cosmetic Act as it relates to the regulation of medical devices. 


        Documenting experience:  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.

        In addition to possess the required specialized experience, you must also meet the degree requirement listed below: 


        Degree: You must have successfully completed a full 4 year course of study, bachelor's or higher degree in professional engineering.  To be acceptable, the curriculum must: (1) be in a school of engineering with at least one curriculum accredited by the Accreditation Board for Engineering and Technology (ABET) as a professional engineering curriculum 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 a 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 professional 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.

        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 further information, visit:

        Conditions of Employment:


        1. Additional Security and Background Requirements:  May be referred depending on the position being filled.  If not previously completed, a background security investigation will be required for all appointees.  Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication.  Failure to successfully meet these requirements may be grounds for appropriate personnel action.  In addition, 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.


        2. All qualification requirements must be met by the closing date of the announcement.


        3. Financial disclosure statement may be required.


        4. Travel, transportation, and relocation expenses will be paid: No


        5. Bargaining Unit Position: No


        6. Drug Screening Required: No


        7. Recruitment Bonus may be authorized: No


        8. Research position: No


        9. Supervisory position: No


        10. Time in grade (TIG) must be met within 30 days of the closing date of the announcement.


        Once the application process is complete, a review of the 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 qualifications and/or experience, you may lose consideration for this position.  Please follow all instructions carefully.  Errors or omissions may affect your eligibility.


        Your qualifications will be evaluated and rated on the following competencies (Knowledge, Skills, Abilities (KSAs') and other characteristics): Please note that you do not need to address the KSAs' separately or in narrative format.  KSAs' will be evaluated against your responses to te online questionnaire. 


        • Knowledge of safety signal management related to the postmarket medical device arena.


        • Skill in communication and collaborative consultation with others.


        • Ability to interpret and apply rules, regulations, and policies related to postmarket devices.


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        The Federal Government offers a comprehensive benefits package.  Explore the major benefits offered to most Federal employees at


        Males born after December 31, 1959 must be registered or exempt from Selective Service (see


        HOW TO APPLY:

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        To begin the process, click the Apply Online button to create an account or log in to your existing USAJOBS account. Follow the prompts to complete the assessment questionnaire.  Please ensure you click the Submit My Answers button at the end of the process.


        Note:  To return to a previously Saved or Incomplete application you may use the following link:


        To fax supporting documents you are unable to upload, complete this cover page using the following Vacancy ID 758686.  Fax your documents to 1-478-757-3144.


        If you cannot apply online:

        1. Click the following link to view and print the assessment questionnaire View Occupational Questionnaire, and
        2. Print this 1203FX form to provide your response to the assessment questionnaire and
        3. Fax the completed 1203FX form along with any supporting documents to 1-478-757-3144.  Your 1203FX will serve as a cover page for your fax transmission.
        4. 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 Bethesda Center HelpDesk Telephone (888)-478-4340; TTY/TDD: (866)-539-4484; or by email  The decision on granting reasonable accommodation will be made on a case-by-case basis.


        To apply for this position, you must provide a complete Application Package which includes:

        1. 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 then you must describe your job-related qualifications that include beginning and ending dates for paid and non-paid work experience, hours worked per week, month and year of employment for each job title listed.

        2. A complete Assessment Questionnaire

        3. Other supporting documents:

        4.      - SF-50 

                - PHS Commissioned Corps Officer must submit a copy of latest personnel order

                - College Transcripts 


          Note:  You may submit an unofficial transcript or a list of college courses completed indicating course titles, credit hours, and grades received.  An official transcript from an accredited educational institution is required if you are selected for the position.


        For Résumé and Application Tips visit:


        The complete Application Package must be submitted by 11:59 PM (EST) on Tuesday, October 16, 2012.


        FDA Helpdesk
        Phone: (888)478-4340
        Fax: (478)757-3144
        Agency Information:
        OHR Bethesda Operations Center
        7700 Wisconsin Ave
        Bethesda, MD
        20814 Fax: (478)757-3144


        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.  We expect to make a selection within 45 days of the closing date of this announcement.

        You will receive notice via email or by mail, if no email address was provided by you during the application process, once this process is completed (generally 4-6 weeks).

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