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-13-871068

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, April 05, 2013 to Thursday, April 18, 2013

SERIES & GRADE:

GS-0806/0830/0850/0858/0893-14

POSITION INFORMATION:

Full Time - Temporary Promotion NTE 1 Year

PROMOTION POTENTIAL:

14

DUTY LOCATIONS:

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

WHO MAY APPLY:

Status Candidates (Merit Promotion and VEOA Eligibles)

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:  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 Program (ICTAP); veterans 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. 

 

YOU MUST SUBMIT YOUR LATEST PAY ACTION SF-50 .

 

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.

 

This is a detail/temporary promotion not to exceed 1 year; may be filled on a rotating basis; may become permanent.

 

This position is being advertised concurrently with HHS-FDA-01-MP-13-870352, Supervisory Interdisciplinary Scientist and HHS-FDA-01-MP-13-871231, Supervisory Medical Officer.  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-806, Materials Engineer; GS-830, Mechanical Engineer; GS-850, Electrical Engineer; GS-858, Biomedical Engineer; or GS-893, Chemical 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 Anesthesiology, General Hospital, Infection Control, Respiratory and Dental Devices/Respiratory Devices Branch. 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.

 

This announcement may be used to fill multiple positions in multiple locations.

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.
  • Submit a copy of your transcripts if applying for a different series.

DUTIES:

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Major Duties:

As the Branch Chief, you will provide technical leadership and expert scientific and engineering judgment for various 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 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 at meetings, if necessary, with foreign manufacturers, health care professionals and government officials, and at international meetings.

·         Conferring with industry officials and medical and/or scientific experts in the various medical device arenas regarding the regulation of various 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-806 series, Materials Engineer; GS-830 series, Mechanical Engineer; GS-850 series, Electrical Engineer; GS-858 series, Biomedical Engineer or GS-893 series, Chemical 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 demonstrate in your resume at least (one) year of qualifying specialized experience equivalent to at least the GS-13 level in the Federal service.  Examples of specialized experience include: 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. 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: Yes

 

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

HOW YOU WILL BE EVALUATED:

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 and other characteristics):

 

1.  Knowledge of medical devices, drug and biologic laws.

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/ResourceCenter/Index/Interactive/Benefits#icc.



OTHER INFORMATION:

 

If you are a veteran with preference eligibility and you are claiming 5-points veterans' preference, you must submit a copy of your DD-214 or other proof of eligibility.  If you are claiming 10-point veterans' preference, you must also submit an SF-15, "Application for 10-Point Veterans' Preference" plus the proof required by that form.  For more information on veterans’ preference see http://www.usajobs.gov/Veterans

 

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 871068.  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/pdf_fill/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.
  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 quickquestions@fda.hhs.gov.  The decision on granting reasonable accommodation will be made on a case-by-case basis.


REQUIRED DOCUMENTS:

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.      - Veterans Preference Documentation, if applicable

         - SF-50 (if you are a federal employee or have reinstatement rights as a federal employee)

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

         - College Transcripts (if the position has a positive education requirement)

 

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: http://www.usajobs.gov/ResourceCenter/Index/Interactive/ResumeAndApplicationTips#icc.

 

The complete Application Package must be submitted by 11:59 PM (EST) on Thursday, April 18, 2013.

AGENCY CONTACT INFO:

FDA Helpdesk
Phone: (888)478-4340
Fax: (478)757-3144
Email: QUICKQUESTIONS@PSC.GOV
Agency Information:
HHS FDA Center
10903 New Hampshire Avenue
Silver Spring, MD
20993 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-13-871068

Control Number:

341140400