Supervisory Interdisciplinary Engineer


Vacancy ID: 793034   Announcement Number: HHS-FDA-01-MP-13-793034   USAJOBS Control Number: 331918000

Social Security Number

Enter your Social Security Number in the space indicated. Your Social Security Number is requested under the authority of Executive Order 9397 to uniquely identify your records from those of other applicants who may have the same name.  As allowed by law or Presidential directive, your Social Security Number is used to seek information about you from employers, schools, banks and others who may know you. Providing your Social Security Number is voluntary, however we can not process your application without it.


Vacancy Identification Number

Enter 793034
1. Title of Job

Supervisory Interdisciplinary Engineer
2. Biographic Data

3. E-Mail Address

4. Work Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

5. Employment Availability

Are you an ICTAP Eligible?

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.


Are you eligible for Indian preference as defined by the Department of the Interior (DOI) and as evidenced by appropriate Bureau of Indian Affairs (BIA) authorized certification?


Are you eligible for preference based on being a Public Law 94-437 Indian Health Service Scholarship recipient? For more information, please click here.    


Are you eligible for the Federal Employment Program for Persons with Disabilities? (For information on Schedule A appointments, see the OPM website.)    


Are you a PHS Commissioned Officer (This includes active duty officers, inactive reserve officers, and applicants who have been approved for commissioning in the USPHS Commissioned Corps)?


Are you eligible for noncompetitive appointment?
This includes applicants who are eligible for special or noncompetitive appointment authorities such as 30% or more compensable disabled veterans, persons with disabilities and PHS Commissioned Corps Officers.  This also includes applicants who meet the qualifications for this position and who have previously held, or currently hold, a Federal position at the grade of this position.


6. Citizenship

Are you a citizen of the United States?
7. Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

8. Other Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

9. Languages

If you are applying by the OPM Form 1203-FX, leave this section blank.

10. Lowest Grade

Enter the lowest grade level that you will accept for this position. The lowest grade for this position is 14.


14

11. Miscellaneous Information

If you are a male at least 18 years of age, born after December 31, 1959, have you registered with the Selective Service System?


01 Yes
02 No
03 Not Applicable

12. Special Knowledge

If you are applying by the OPM Form 1203-FX, leave this section blank.

13. Test Location

If you are applying by the OPM Form 1203-FX, leave this section blank.

14. Veteran Preference Claim

15. Dates of Active Duty - Military Service

16. Availability Date

17. Service Computation Date

If you are applying by the OPM Form 1203-FX, leave this section blank.

18. Other Date Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

19. Job Preference

Please select from the list below at least one Branch in which you are interested.  You may select more than one.  The Branch(es) you select will determine the position(s) for which you will be considered.
01 Division of Cardiovascular Devices (DCD), Cardiac Diagnostics Devices Branch (CDDB)
02 Division of Cardiovascular Devices, Peripheral Interventional Devices Branch (PIDB)
03 Division of Cardiovascular Devices, Circulatory Support Devices Branch (CSDB)
04 Division of Neurological and Physical Medicine Devices (DNPMD), Neurostimulation Devices Branch (NSDB)
05 Division of Neurological and Physical Medicine Devices, Physical Medicine and Neurotherapeutic Devices Branch (PNDB)
06 Division of Orthopedic Devices (DOD), Joint and Fixation Devices Branch 2 (JFDB2)
07 Division of Orthopedic Devices, Anterior Spine Devices Branch (ASDB)
08 Division of Surgical Devices (DSD), General Surgery Devices Branch 2 (GSDB2)
09 Division of Surgical Devices, Plastic and Reconstructive Surgery Devices Branch 2 (PRSB2)
10 Division of Ophthalmic and Ear, Nose and Throat Devices (DOED), Contact Lenses and Retinal Devices Branch (CLRDB)
11 Division of Anesthesiology, General Hospital, Infection Control and Dental Devices (DAGID), Respiratory Devices Branch (RDB)
12 Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD), Gastroenterology Devices Branch (GRDB)

20. Occupational Specialties

Select/enter at least one occupational specialty. The specialty code for this position is:


001 General Engineer
002 Materials Engineer
003 Mechanical Engineer
004 Electrical Engineer
005 Electronics Engineer
006 Biomedical Engineer

21. Geographic Availability

Select/enter at least one geographic location in which you are interested and will accept employment. The location code for this position is:


241450031 Silver Spring, MD

22. Transition Assistance Plan

23. Job Related Experience

If you are applying by the OPM Form 1203-FX, leave this section blank.

24. Personal Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

25. Occupational/Assessment Questions:

1. From the description below, select the one which best describes your education and/or experience and meets the Basic Qualification Requirements for a Supervisory Interdisciplinary Engineer, GS-801, 806, 830, 850, 855, 858.

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: 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. 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. 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. 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.) Note: An applicant who meets the basic requirements as specified in A or B above may qualify for positions in any branch of engineering unless selective factors indicate otherwise, or unless he/she qualifies under the provisions of B.2 related to the EIT examination or BET degree.
C. I do not possess the education and/or experience described above.

2. From the description below, select the one which best describes your experience and meets the Additional Qualification Requirements for a Supervisory Interdisciplinary Engineer, GS-801,806,830,850,855,858-14.

A. I have 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.
B. I do not possess the specialized experience described above.

3. Are you a permanent Food and Drug Administration employee?

A. Yes
B. No

For each task in the following group, choose the statement from the list below that best describes your experience and/or training. Darken the oval corresponding to that statement in Section 25 of the Qualifications and Availability Form C. Please select only one letter for each item.

A- I have not had education, training or experience in performing this task.
B- I have had education or training in performing the task, but have not yet performed it on the job.
C- I have performed this task on the job. My work on this task was monitored closely by a supervisor or senior employee to ensure compliance with proper procedures.
D- I have performed this task as a regular part of a job. I have performed it independently and normally without review by a supervisor or senior employee.
E- I am considered an expert in performing this task or I have supervised performance of this task or am normally the person who is consulted by other workers to assist them in doing this task because of my expertise.

4. Manages 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.

5. Provides 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 devices.

6. Serves as a focal point, advisor and primary contact for medical device regulatory and scientific issues relative to various products/submissions.

7. Provides 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.

8. Provides technical consultation of various medical device products.

9. Participates in technical work groups where the safety and effectiveness of medical devices are discussed.

10. Plans and organizes activities of the Division, such as review of reclassification petitions, premarket approval and research programs.

11. Serves as a technical expert and advisor in the area of preclinical and clinical testing of various medical devices as they relate to investigational device exemptions, premarket notifications and applications for premarket approval.

12. Coordinates the work of Division personnel in the administrative, regulatory and scientific review of pre-market notifications and petitions.

13. Provides guidance involving complex questions of opinion and policy.

14. Provides overall management and administrative direction to the clerical and professional staff.

15. Reviews and evaluates scientific activities in terms of achieving program goals and objectives and accomplishing assigned functional responsibilities.

16. Provides technical and clinical guidance to the staff on precedent setting and controversial issues involving complex questions of opinion and policy.

17. Represents the Division Director at meetings, if necessary, with foreign manufacturers, health care professionals and government officials and at international meetings.

18. Participates in inter-Agency task groups as an expert or senior reviewer and also participates in technical working groups in other Agencies or Centers.

19. Confers with industry officials and medical and/or scientific experts in the various medical device areas or other medical device arenas regarding the regulation of various device products.