Biomedical Engineer


Vacancy ID: 758686   Announcement Number: HHS-FDA-MP-13-758686   USAJOBS Control Number: 327986900

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 758686
1. Title of Job

Nurse Consultant
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 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

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

15. Dates of Active Duty - Military Service

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

16. Availability Date

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

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

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

20. Occupational Specialties

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


001 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:


241679031 White Oak, MD

22. Transition Assistance Plan

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

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. Please select one response from the responses listed below that best indicates how you meet the education requirement for a Biomedical Engineer, GS-858-14 position.

A. You must have successfully completed a full 4 year course of study, bachelor's or higher degree in 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 OR a 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.
B. I do NOT possess the degree and registration required as listed in A above to qualify for the GS-858-14 position.

You must meet the specialized experience requirement for this position. You must possess at least one year of specialized experience as described below:

2. Please select one response from the responses listed below that best indicates how you meet the specialized experience for a Biomedical Engineer, GS-858-14 position.

A. I possess at least one year of specialized experience equivalent to at least the GS-13 grade level in the Federal service. Examples include significant experience with the following: applying advanced engineering theories, principles, concepts, standards, and methods to provide expert advice to senior colleagues and/or agency officials regarding medical device issues. Work with the application of good clinical practices, human subject protections, clinical research, and recent developments allowing to review and provide recommendations to issues and questions related to the regulated industry and medical devices. Work that allowed collaborative working relationships with others at different levels within the organization. Experience presenting findings and recommendations in scientific terms, both verbally and in writing, including identifying and clearly presenting problems, proposals, and making recommendations, providing expert guidance to management and/or other staff at different levels within the
organization. Experience working as an expert with scientific properties, analysis, behavior, and the impact of these properties as it relates to diagnostic tests and safety and effectiveness of medical devices. Experience with work involving the Federal Food, Drug, and Cosmetic Act as it relates to the regulation of medical devices.
B. I do NOT possess the specialized experience required and as described in letter A above to qualify for the GS-858-14 position.

Please select the response that is applicable to you.

3. Are you?

A. A current Food and Drug Administration (FDA) Career or Career-Conditional employee with competitive status only. Competitive status refers to employees who are serving on a career or career-conditional appointment.
B. A Public Health Service (PHS) Commissioned Corps currently working for the Food and Drug Administration (FDA). 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.
C. None of the responses listed above are applicable to me.

For each of the following task statements, select one response below (A-E) that best describes your experience level. You must select a response for each question.

A- I have no experience in performing this task.
B- I have limited experience in performing this task. I have had exposure to this task but would require additional guidance, instruction, or experience to perform it at a proficient level.
C- I have experience performing this task across routine or predictable situations with minimal supervision or guidance.
D- I have performed this task independently across a wide range of situations. I seek guidance in carrying out this task only in unusually complex situations.
E- I am considered an expert in carrying out this task. I advise and instruct others in carrying out this task on a regular basis. I am consulted by my colleagues and/or superiors to carry out this work behavior in unusually complex situations.

4. Participate in the analysis of identified postmarket safety issues.

5. Coordinate timely and effective identification of postmarket safety signal issues within a team or a cross-functional group of experts in the postmarket medical device arena or related fields.

6. Provide recommendations and guidance regarding medical device safety issues to higher level management and other staff.

7. Lead and participate in the design and solution development for postmarket safety issues.

8. Present clinical and other technical information to a variety of audiences.

9. Represent the organization at meetings and conferences.

10. Research, write/create, and edit documents to communicate scientific and technical information to a variety of audiences.

11. Interpret and apply rules, regulations and policies as governed by the Food Drug and Cosmetic Act.

12. Coordinate, consult, and facilitate the sharing of information supporting regulatory efforts to ensure the safety of postmarket medical devices.

13. Lead multi-disciplinary team(s) in information gathering, compilation, analysis and solution development for device related safety issues.