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

Job Title:Supervisory Interdisciplinary Engineer

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-01-MP-13-761150

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

The contents of the announcement can still be viewed.

SALARY RANGE:

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

OPEN PERIOD:

Friday, October 05, 2012 to Monday, October 15, 2012

SERIES & GRADE:

GS-0801/0806/0850/0858-14

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

14

DUTY LOCATIONS:

1 vacancy in the following location:
Silver Spring, MD United StatesView Map

WHO MAY APPLY:

Food and Drug Administration employees only

JOB SUMMARY:

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.

Who May Apply:

This vacancy is open to current permanent Title 5 Food and
Drug Administration employees and individuals eligible under CTAP
only.  Title 42 employees are not eligible.  YOU MUST SUBMIT YOUR SF-50. 

PHS Commissioned Officers in the Food and Drug Administration interested in performing the duties
of this position should also apply online in order to receive
consideration.

This vacancy is also being announced concurrently with HHS-FDA-01-MP-13-761319, Supervisory Interdisciplinary Scientist.  NOTE: Applicants must apply separately for each announcement in order to be considered. 

This position will be filled in one of the following occupational series:  GS-801, General Engineer; GS-806, Materials Engineer; GS-850, Electrical Engineer or GS-858, Biomedical Engineer.

This position is located in the Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Division of Reproductive, Gastro-Renal and Urological Devices 

This position has supervisory/managerial responsibilities.
A one-year supervisory/managerial probationary period is required
upon selection/placement.  This may be waived if you have
successfully completed the supervisory/managerial probationary
period.

Salary range listed includes locality pay.

Additional selections may be made from this announcement.

KEY REQUIREMENTS

  • U.S. Citizenship is required.
  • Travel Required: Occasional
  • Please carefully read and follow the instructions for HOW TO APPLY.
  • Please submit SF-50.
  • Please submit a copy of your transcripts.

DUTIES:

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Major Duties:

As the Branch Chief, you will provide technical leadership and expert scientific and engineering judgment for various urology and lithotripsy medical devices.  Duties include:

·         Managing a staff of scientists, engineers, CSOs and health care professionals in the administrative, regulatory and scientific review of pre-market notifications (510(k)s), IDEs, PMAs and reclassification petitions.  

·         Providing technical leadership and judgment in the evaluation of complex issues involving devices which have a significant impact on the safety and effectiveness of various urology and lithotripsy medical devices or other medical device products.

·         Providing expert and authoritative advice, guidance, assistance, interpretations, consultations and recommendations to top level and senior Agency and Departmental officials, program directors, scientific and professional personnel and industry representatives.

 ·       Coordinating the work of personnel which include Scientists, Engineers, Consumer Safety Officers, Health Care Professionals and support personnel in the administrative, regulatory and scientific review of pre-market notifications and petitions.

·         Providing overall management and administrative direction to the clerical and professional staff.

·         Reviewing and evaluating scientific activities in terms of achieving program goals and objectives and accomplishing assigned functional responsibilities.

 

·         Representing the Division Director or Deputy Director at various meetings, if necessary, with foreign manufacturers, health care professionals and/or government officials.

·         Conferring with industry officials and medical and/or scientific experts in the urology and lithotripsy device area regarding the regulation of these device products. 


QUALIFICATIONS REQUIRED:

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QUALIFICATIONS REQUIRED:

Interdisciplinary positions are classified to the specific series which have been determined to be appropriate for the vacancy based on the duties and responsibilities of the positions and the general qualifications to perform the work.

 

Basic Requirements for the GS-801 series, General Engineer; GS-806 series, Materials Engineer; GS-850 series, Electrical Engineer or GS-858 series, Biomedical Engineer: 

 

A.    Degree: 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.

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 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. The adequacy of such background must be demonstrated by one of the following:

A.    Professional registration -- Current registration as a professional engineer 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.

B.     Written Test -- Evidence of having successfully passed the Engineer-in-Training (EIT) examination, or the written test required for professional registration, which is administered by the Boards of Engineering Examiners in the various States, the District of Columbia, Guam, and Puerto Rico.

Applicants who have passed the EIT examination and have completed all the requirements for either (a) a bachelor's degree in engineering technology (BET) from an accredited college of university that included 60 semester hours of courses in the physical, mathematical, and engineering sciences, or (b) a BET from a program accredited by the Accreditation Board for Engineering and Technology (ABET) may be rated eligible for certain engineering positions at GS-5. Eligibility is limited to positions that are within or closely related to the specialty field of the engineering technology program. Applicants for positions that involve highly technical research, development, or similar functions requiring an advanced level of competence in basic science must meet the basic requirements in paragraph A.

Because of the diversity in kind and quality of BET programs, graduates of other BET programs are required to complete at least 1 year of additional education or highly technical work experience of such nature as to provide reasonable assurance of the possession of the knowledge, skills, and abilities required for professional engineering competence. The adequacy of this background must be demonstrated by passing the EIT examination.

C.     Specified academic courses -- Successful completion of at least 60 semester hours of courses in the physical, mathematical, and engineering sciences and in engineering that included the courses specified in the basic requirements. The courses must be fully acceptable toward meeting the requirements of a professional engineering curriculum as described in paragraph A.

D.    Related curriculum -- Successful completion of a curriculum leading to a bachelor's degree in engineering technology or in an appropriate professional field, e.g., physics, chemistry, architecture, computer science, mathematics, hydrology, or geology, may be accepted in lieu of a 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.)

AND 

In addition, you must possess one year of specialized experience equivalent to at least the GS-13 level in the Federal service, serving as a scientific or engineering reviewer, supervisor or senior advisor in the area of  medical device evaluation as it relates to the review and evaluation of  premarket notification submissions, premarket applications and/or  investigational device exemptions for premarket approval prior to entry into the marketplace.


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: http://www.ed.gov/.

Conditions of Employment:

1. Security and Background Requirements: 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. 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.

3. Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.

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

5. Financial disclosure statement may be required.

6. One-year probationary period may be required.

7. Travel, transportation, and relocation expenses will not be paid.

8. Bargaining Unit Position: No

9. Drug Screening Required: No

10. Recruitment Bonus may be authorized:  No

11. Time in grade (TIG) must be met by closing date of the announcement.

HOW YOU WILL BE EVALUATED:

Once the application process is complete, a review of 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 on the following competencies (knowledge, skills, abilities and other characteristics):

1.  Knowledge of medical devices, drug and biologic laws; including the knowledge of FDA and ODE policies and guidelines, CFRs and parts of the FD&C Act.

2.  Skill in coordinating the scientific and technical workflow of the staff; managing scientific activities and the ability to manage a multidisciplinary team of scientists, engineers, etc.

3.  Ability to prioritize workloads and make complex scientific decisions.

4.  Knowledge of various medical device products and the ability to review research and clinical studies. 


BENEFITS:

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The Federal Government offers a comprehensive benefits package. Explore the major benefits offered to most Federal employees at http://www.usajobs.gov/ei/benefits.asp#icc.



OTHER INFORMATION:

Males born after December 31, 1959 must be registered or exempt from Selective Service (see http://www.sss.gov).

For information on "People with Disabilities" please visit http://opm.gov/disability/PeopleWithDisabilities.asp

Interagency Career Transition Assistance Program (ICTAP):  For information on how to apply as an ICTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ictap.  To be well-qualified and exercise selection priority for this vacancy, displaced Federal employees must be rated at **85.0 or above on the rating criteria for this position.





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: https://applicationmanager.gov/.

 

To fax supporting documents you are unable to upload, complete this cover page http://staffing.opm.gov/pdf/usascover.pdf using the following Vacancy ID 761150.  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 http://www.opm.gov/forms/pdfimage/opm1203fx.pdf 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.

The following documents are required and must be received by the closing date of this announcement:

1. Your Resume'
2. A complete Assessment Questionnaire
3. Other supporting documents:
    - Veterans Preference Documentation, if applicable
    - College transcript, if applicable

For Resume' and Application Tips visit: http://www.usajobs.gov/EI/resumeandapplicationtips.asp#icc



REQUIRED DOCUMENTS:

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

 

1. Your Résumé

2. A complete Assessment Questionnaire

3. Other supporting documents:

         - Veterans Preference Documentation, if applicable
              - College Transcripts, if applicable

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.
 

The complete Application Package must be submitted by 11:59 PM (EST) on Monday, October 15, 2012.

AGENCY CONTACT INFO:

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

WHAT TO EXPECT NEXT:

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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Job Announcement Number:

HHS-FDA-01-MP-13-761150

Control Number:

328166000