If selected for this position, you will:
Provide technical expertise in one or more of the following digital health focus areas: software lifecycle management processes (premarket and postmarket) , mobile medical apps, interoperability, cybersecurity, wireless, cloud, machine learning/artificial intelligence, big data, and advanced analytics;
Provide expertise and serves as the CDRH resource in the application of existing digital health policies to promote innovation while balancing benefit and risk for digital health products;
Develop regulatory policy in one or more of the following digital health focus areas: software lifecycle management processes (premarket and postmarket) mobile medical apps, interoperability, cybersecurity, wireless, cloud, machine learning/artificial intelligence, big data, and advanced analytics;
Participate as a subject matter expert, when necessary in premarket and post-market review of digital health products;
Research and review trends on innovative digital health technologies and provide authoritative guidance and recommendations.
In order to be qualified for an Interdisciplinary Engineer, GS-0854-0858 position, you must meet the following:
A. Have successfully completed 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. - OR -
B. Have successfully completed 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. - OR -
C. Possess a current registration as a professional engineer by any State, the District of Columbia, Guam, or Puerto Rico. - OR -
D. Have passed the Engineer-in-Training (EIT) examination, and in addition, have a combination of education in the field of general engineering and professional engineering experience which totals at least four years. - OR -
E. Have completed 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, have professional general engineering experience which, when combined with my education as described above, totals at least four years. - OR -
F. Have 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, have at least one year of professional engineering experience acquired under professional engineering supervision and guidance.
In addition, in order to be qualified at the GS-14 level, you must possess one year of specialized experience, equivalent to the GS-13 level in the Federal service, which includes serving as a scientific or engineering reviewer, or senior advisor in the area of medical device evaluation as it relates to the review and evaluation of digital health activities, medical device software and medical device products.
If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. 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.
Conditions of Employment: 1. Security and Background Requirements: Appointment will be subject to the applicant's successful completion of a background security investigation. Failure to successfully meet these requirements may be grounds for appropriate personnel action. 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 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. Pre-employment physical required: No5. Drug testing required: No6. License required: No7. Mobility agreement required: No8. Immunization required: No9. Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.10. Bargaining Unit Position: No11. All qualification requirements must be met by the closing of the announcement.12. Financial disclosure statement required: No
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.
In the last five years, based on the closing date of this announcement, IF you served or you are currently serving as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire.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 (Member 4 copy) 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
Career Transition Program: This program applies to Federal workers whose positions have been deemed "surplus" or no longer needed, or an employee who has been involuntarily separated from a Federal service position within the competitive service. To receive selection priority for this position, you must be rated "well-qualified". Well-qualified means eligible applicants whose knowledge, skills, and abilities clearly exceed the minimum qualification requirements of the position. For information on how to apply and what documents to submit as an ICTAP eligible, see: http://www.opm.gov/rif/employee_guides/career_transition.asp
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