Duties

Summary

This position is being filled through the Direct Hire Authority for this occupation and is open to all US Citizens. All applicants who meet the basic and minimum qualification requirements will be forwarded to the Selecting Official for consideration. This position is located in the Center of Devices and Radiological Health in Silver Spring, MD. Additional selections may be made within the same geographical area FDA-wide.
Learn more about this agency

Responsibilities

• The Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health.
• It assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.
• CDRH provides consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee.
• The Center facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.
• This position is located in the Office of the Center Director (OCD), Quality Management Staff. As a General Engineer in the Office of the Center Director (OCD), Quality Management Staff, you will:
• Perform a variety of engineering duties to support the development, implementation, monitoring and audition of CDRH quality management and operational excellence efforts
• Conduct engineering studies to critique, design, and improve quality management planning and performance systems, surveys, and decision models in CDRH programs to improve their efficiency and effectiveness
• Assists senior analysts with preparation of surveys, questionnaires, or other data sampling tools to collect data relevant to the performance of CDRH programs and projects.
• Prepare detailed reports, analyses, presentations for CDRH management and staff in support of recommended changes to quality assurance/management processes

Travel Required

25% or less - You may be expected to travel for this position.

Supervisory status
No

Promotion Potential
13

Requirements

Conditions of Employment

• This position may be subject to completion of a 1-year probationary period (unless you have already satisfied this obligation).
• Citizenship Requirement: You must be a U.S. Citizen or U.S. National to be considered for this advertisement. Foreign nationals or legal permanent residents are not eligible for consideration.
• Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
• Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Research Positions may require evaluation of the scientific contributions, recognition, and professional standing of the researcher, and may be subject to peer review. A writing sample or publication portfolio may also be required.
• If you were born male, after, December 31st 1959, you must be registered with the Selective Service System, or have an approved exemption. Learn more at www.SSS.gov.
• Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities. Your application may be shown to multiple hiring offices.
• You may be asked to provide additional information at a later time. All interviews requests and selection decisions are at the full discretion of the hiring office.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.

Qualifications

BASIC QUALIFICATIONS:
In order be eligible for the position of General Engineer, (GS-0801-11/12/13) , you must meet the following requirements...

A.Degree: 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)1 , or licensure as a Professional Engineer (PE) by any State, the District of Columbia, Guam, or Puerto Rico. Absent other means of qualifying under this standard, those applicants who achieved such registration by means other than written test (e.g., State grandfather or eminence provisions) are eligible only for positions that are within or closely related to the specialty field of their registration. For example, an applicant who attains registration through a State Board's eminence provision as a manufacturing engineer typically would be rated eligible only for manufacturing engineering positions.
2. Written Test -- Evidence of having successfully passed the Fundamentals of Engineering (FE) 2 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.
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 QUALIFICATIONS REQUIREMENTS:

For further consideration for the General Engineer, GS - 0801-11/12/13 , in addition to the basic education requirement listed above, you must meet the following requirements for each grade level for which you wished to be considered .

TO QUALIFY FOR THE GS-11
A. Have one year of specialized experience, equivalent to the GS-09 grade level in the Federal service: Providing engineering and analytical expertise in consulting on a wide variety of scientific and quality management issues and matters. Assist in evaluating and resolving problems related to quality management processes. OR

B. Three years of progressively higher level graduate education leading to a Ph.D. in a related field.

OR

C. Have a combination of experience as described in "A" above and graduate education as described in "B" above. When combining education with experience, first determine the applicant's total qualifying education as a percentage of the education required for the grade level; then determine the applicant's experience as a percentage of the experience required for the grade level; finally, add the two percentages. The total percentage must equal at least 100 percent to qualify.

TO QUALIFY FOR THE GS-12:
Have one year of specialized experience, equivalent to the GS-11 grade level in the Federal service: Advising on compliance standards related to scientific and quality management issues and matters. Collaborating with other scientists, engineers, healthcare professionals within an organization/agency on a wide range of scientific issues as they relate to the management and execution of technical processes and quality management program activities. Recommending program enhancements related to technical processes and procedures and quality management program core procedures.

TO QUALIFY FOR THE GS-13:
Have one year of specialized experience, equivalent to the GS-12 grade level in the Federal service: Planning, developing and administering technical and quality management programs. Evaluating the impact of procedures on scientific policies and on overall activities and priorities under a quality management program. Developing and conducting quality management system core activities.

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.

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply through this announcement. Candidates will be referred as Commissioned Corps personnel and not as candidates for conversion to a permanent career or career-conditional appointment.

All qualification requirements must be met by 11:59 pm (Eastern Time) on 11/18/2019 . If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities.

Education

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; or full credit has been given for the courses at a U.S. accredited college or university.

For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation .

Additional information

We may make additional selections for similar positions across the entire Department of Health and Human Services (HHS) within the local commuting area(s) identified in this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s) at HHS. There is no option to opt-out as your information will not be shared with other hiring agencies outside of HHS.
Additional Conditions of Employment:

• Pre-employment physical required: No
• Drug testing required: No
• License required: ,No
• Mobility agreement required: No
• Immunization required: No
• Bargaining Unit Position: Yes / 3591
• 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
• Interview Process: Structured interviews: may be asked scenario-based interview questions concerning core competencies. Method/tools used to evaluate applicants: work samples, conducting a presentation, reference checks, tests may be used.
• Scientific Research Positions: Research positions require an evaluation of the scientific contributions, recognition and professional standing of the researcher as they related to the position being filled.
• Writing Samples & Portfolios: A writing sample or publication portfolio may be required.
• Peer Review: Some scientific and research positions may be subject to peer review.
• Selecting Service Registration: If you were born male, after, December 31st 1959, you must be registered with the Selective Service System, or have an approved exemption. Learn more at www.SSS.gov .

Additional Information:

• If you are serving, or have served in the last 5 years (from 11/18/2019) 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. See Political Appointee FAQ - OPM for more..
• Reasonable Accommodation: This agency provides reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please contact the Bethesda Center Help Desk (888) 478-4340; TTY/TDD: (866) 539-4484; or by email quickquestions@fda.hhs.gov . The decision on granting reasonable accommodation will be made on a case-by-case basis. See the Reasonable Accommodation Policy for more information...

How You Will Be Evaluated

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

Once the job opportunity announcement closes (at 11:59 pm ET on 11/18/2019), your resume and all supporting documents will be reviewed by HR to determine your eligibility for Federal employment and your qualification for this position specifically.

This is a direct hire announcement. Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy. We will evaluate you against the basic qualifications. Qualified applicants will be referred for consideration in accordance with the Office of Personnel Management direct hire guidelines.

Please follow all instructions carefully. Errors or omissions may affect your eligibility.

Equal Employment Opportunity: The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor See the EEO Policy for more information...

Background checks and security clearance

Security clearance
Not Required

Drug test required
No

Position sensitivity and risk
Non-sensitive (NS)/Low Risk

Trust determination process
Suitability/Fitness

Required Documents

• Resume
• Transcript

A document that is required must be submitted by all applicants because the document is needed to verify your qualifications, education, or other eligibility information. Failure to provide one of the documents in the list below may result in your application being considered incomplete.

• Cover Letter
• DD-214/ Statement of Service
• Disability Letter (Schedule A)
• Disability Letter (VA)
• License
• Other supporting documentation not listed above
• PCS Orders
• Performance Appraisal
• Professional Certification
• Resume
• Separation Notice (RIF)
• SF-15
• SF-50/ Notification of Personnel Action
• Transcript

These documents may be required for some applicants . Applicants relying on education to qualify, those seeking consideration under a special hiring authority, or those who need to verify a license or certification, will need to submit appropriate supporting documentation from this list. RESUME REQUIREMENTS:
The federal government has very specific resume requirements. If you have not written a federal resume before, you should watch this Resume Writing Tutorial video on the USAJOBS YouTube channel , or read through a helpful Resume Writing FAQ on the USAJOBS Help Site to learn what details you should, and should not, include in your resume.
At a minimum your resume should list the position title, employer, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position listed. A CV (curriculum vitae) may not contain enough information to meet these resume requirements.

Learn more about supporting documents and documentation requirements on USAJOBS:

• How to Understand the Required Documents Section
• What Types of Documents May I Need?
• How to Manage Your Documents on USAJOBS

If you are relying on your education to meet qualification requirements:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education .

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.