Clarification from the agency

Status Candidates (this includes Merit Promotion, Status Candidates, Former Overseas Employees, CTAP, ICTAP, VEOA, 30% or More Disabled Veterans, Schedule A, Military Spouses, Americorps, Peace Corps, Vista, USPHS officers, and Interchange Agreement Eligibles)

The Interdisciplinary Engineer performs the following duties:

• Providing technical expertise in one or more of the following digital health focus areas: software lifecycle management processes, medical device software, mobile medical applications, interoperability, cybersecurity, wireless, cloud, machine learning/artificial intelligence, and big data and advanced analytics.
• Researching and evaluating regulatory policy in one or more of the above digital health focus areas.
• Providing expertise and serving as an advisor in consistent application of existing digital health policies to promote innovation while balancing benefit and risk for digital health products.
• Identifying opportunities and risks for modifying CDRH's digital health approach to premarket review and postmarket surveillance of medical devices to promote timely, efficient scientific assessment and review of innovative products.
• Researching and reviewing trends on innovative digital health technologies and provide authoritative guidance and recommendations.

Conditions of employment

Additional Conditions of Employment:

1. U.S. Citizenship is required.
2. One-year probationary period may be required.
3. Must meet time-in-grade restrictions by closing date of announcement.
4. Registered or exempt from Selective Service (www.sss.gov).
5. 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 and/or appropriate disciplinary action.
6. 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.
7. Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
8. Pre-employment physical required: No
9. Drug testing required: No
10. License required: No
11. Mobility agreement required: No
12. Immunization required: No
13. 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.
14. Bargaining Unit Position: Yes
15. All qualification requirements must be met by the closing of the announcement.
16. Financial disclosure statement required: No

Qualifications

Time-in-Grade: One year at the GS-12 level is required ro meet the time-in-grade requirements for the GS-13 level.Under competitive merit promotion procedures, any individual who is currently holding, or who has held within the previous 52 weeks, a General Schedule position under a non-temporary appointment in the competitive or excepted service, must meet "time-in-grade" requirements (have served 52 weeks at the next lower grade of the grade for which you are applying). Time-In-Grade requirements also apply to current employees applying for a Veterans Employment Opportunities Act of 1998 (VEOA) appointment. NOTE: You must provide a copy of your SF-50 (you may need to submit more than one), "Notice of Personnel Action" that indicates proof of status and time-in-grade eligibility. The SF-50 must include your position, title, series, grade, step, tenure, type of service (Competitive or Excepted) and career status (career or career-conditional).

In order to be qualified for this position, you must meet the basic requirement in one of the following ways AND minimum qualification requirement as noted below:

Basic Requirement:
A. Possess a bachelor's or higher degree in Engineering. To be acceptable, the program must: (1) lead to a bachelor's degree in a school of engineering with at least one program accredited by ABET; 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
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 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:

1. Professional registration or licensure -- Current registration as an Engineer Intern (EI), Engineer in Training (EIT), or licensure as a Professional Engineer (PE) by any State, the District of Columbia, Guam, or Puerto Rico. (You must submit licensure or registration for confirmation under this provision.)

2. Written Test -- You must submit evidence of having successfully passed the Fundamentals of Engineering (FE) examination or any other written test required for professional registration by an engineering licensure board in the various States, the District of Columbia, Guam, and Puerto Rico under this provision.

3. Specified academic courses -- Successful completion of at least 60 semester hours of courses in the physical, mathematical, and engineering sciences and that included the courses specified in the basic requirements under paragraph A. The courses must be fully acceptable toward meeting the requirements of an engineering program as described in paragraph A.

4. Related curriculum -- Successful completion of a curriculum leading to a bachelor's degree in an appropriate scientific field, e.g., engineering technology, physics, chemistry, architecture, computer science, mathematics, hydrology, or geology, may be accepted in lieu of a bachelor's 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.)

Minimum Qualification Requirement GS-13:
In addition, to be qualified at the GS-13 level, you must possess one full year of specialized experience equivalent to at least the GS-12 grade level in the Federal service performing duties such as:

• Performing practical software engineering work for commercializing digital health products or medical devices.
• Providing guidance and advising other engineers or scientists on topics concerning software-related medical device and digital health policy.
• Analyzing and evaluating policies that impact digital health products.

(This experience must be clearly demonstrated in your resume).

IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE MAY NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. If your resume does not support your questionnaire answers, we will not allow credit for your response(s).

NOTE: Experience refers to paid and unpaid experience, including volunteer work done through national Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to gain employment. You will receive credit for all qualifying experience, including volunteer experience. If such experience is on a part-time basis, you must provide the average number of hours worked per week as well as the beginning and ending dates of the experience so it can be fully credited.

Documenting experience: In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.

How you will be evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

Once the application process is complete, a review of the resume 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 resume and or supporting documentation, a determination is made that you have inflated your qualifications and or experience, you may lose consideration for this position. Please follow all instructions carefully. Errors or omissions may affect your eligibility.

For Competitive Merit Promotion and Veterans Employment Opportunities Act (VEOA) Applicants: The highest rated candidates will be referred to the hiring agency.

For Noncompetitive Appointment Eligibles: All qualified candidates will be referred to the hiring agency.

Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics).

• Engineering and Technology
• Medical Devices and Products
• Oral Communication
• Software Engineering
• Writing

If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration. These assessment methods/tools may also be listed under Key Requirements.

To preview the assessment questionnaire, click the following link: https://apply.usastaffing.gov/ViewQuestionnaire/10069209