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.
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.
Enter the lowest grade level that you will accept for this position. The lowest grade for this position is 14.
If you are a male at least 18 years of age, born after December 31, 1959, have you registered with the Selective Service System?
Select/enter at least one occupational specialty. The specialty code for this position is:
Select/enter at least one geographic location in which you are interested and will accept employment. The location code for this position is:
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-806, 830, 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.
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-806,830,858-14.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.
3. Are you a permanent Food and Drug Administration employee?A. Yes
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.
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 cardiovascular 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 cardiovascular devices are discussed.
10. Plans and organizes activities of the Branch, 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 cardiovascular devices as they relate to investigational device exemptions, premarket notifications and applications for premarket approval.
12. Coordinates 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.
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 circulatory support and prosthetic device area regarding the regulation of these device products.