All applicants must supply transcripts or other supporting documentation that demonstrates how you meet the educational requirements for the series for which they are applying. Documentation may include a course analysis or description from the college catalog. All documentation must be submitted at the time of application. Failure to do so will result in your disqualification.
Applicant must possess the basic education requirements AND specialized experience to qualify for this position.
Basic Education Requirements:
A. Successful completion of a four year course of study leading to a Bachelor's or higher degree in professional engineering from a school of engineering with at least one curriculum accredited by the Accreditation Board for Engineering and Technology (ABET) as a professional engineering curriculum. (You must submit a copy of your transcript showing the demonstrated coursework at time of application submission). OR
B. Successful completion of a four year course of study leading a Bachelor's degree in professional engineering that included 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. (You must submit a copy of your transcript showing the demonstrated coursework at time of application submission). OR
C. Possession of a current registration as a professional engineer by any State, the District of Columbia, Guam, or Puerto Rico. (You must submit proof of this at time of application submission) OR
D. Successful completion of the Engineer-in-Training (EIT) examination, and in addition, a combination of education in the field of general engineering and professional engineering experience which totals at least four years. (You must submit proof of this at time of application submission) OR
E. Successful completion of at least 60 semester hours of course work in the physical, mathematical, and engineering sciences. This course work included differential and integral calculus, as well as courses in at least five of the seven areas listed in response (B). Also, I have professional general engineering experience which, when combined with my education as described above, totals at least four years. (You must submit a copy of your transcript showing the demonstrated coursework at time of application submission). OR
F. Possession of a Bachelor's or higher degree in engineering technology, chemistry, physics, architecture, computer science, mathematics, hydrology, geology, or another scientific field directly related to engineering. In addition, I have at least one year of professional engineering experience acquired under professional engineering supervision and guidance. (You must submit a copy of your transcripts showing the demonstrated coursework and proof documenting 1 year experience acquired under the supervision of a professional engineer at the time of application submission). AND
Specialized Experience: Applicants must possess at least one year of specialized experience managing/providing leadership direction to segments of a program related to regulatory, scientific or compliance activities involving medical device products; writing policies related to regulatory science programs; and serving as senior advisor in the area of medical device or regulatory product review evaluations.
This position requires specific coursework and/or a degree to meet the basic education requirement. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. Your transcript(s) must clearly demonstrate the course(s) listed in the qualification requirement section. If the transcript(s) does not clearly demonstrate this you must submit a copy of the course description and/or other documentation demonstrating that the courses are equivalent. Degree requirements must be met within 30 days of the closing date of this job announcement and your transcript(s) submitted must reflect this.
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. For further information,click on foreign education.
All qualification requirements must be met by 11:59 PM (Eastern Time) on the closing date of this vacancy announcement.
Failure to provide any of the above will result in an ineligible rating.
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 is required.
6. One-year probationary period may be required.
7. Travel, transportation, and relocation expenses paid: No
8. Bargaining Unit Position: No
9. Drug Screening Required: No
10. Recruitment incentives may be authorized: No
11. Student loan repayment incentive authorized: No
12. Annual leave for non-federal service authorized: No
13. Travel Required - 5%
HOW YOU WILL BE EVALUATED:
Once the job opportunity announcement closes, a review of your résumé 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 résumé and supporting documentation, a determination is made that you have inflated your responses when compared to your background information, your score may be adjusted to more accurately reflect your skills and abilities Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Qualified candidates will be assigned to the following quality categories:
Best Qualified - Applicants who have experience that is almost identical to those required by the position.
Well Qualified - Applicants who have experience that is very similar to those required by the position.
Qualified - Applicants who meet minimum qualification requirements, but do not identify any additional qualifying experience or skill.
The category assignment is a measure of the degree in which your background matches the required competencies listed below for this position.
Technical Competence - medical device, drug, or biological laws, and regulations
Application of Veterans' Preference: Under Category Rating procedures, veteran preference eligibles will receive selection consideration before non-preference eligibles within each quality category.
To preview the assessment questionnaire, click the following link: View Assessment Questions