Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.
This is an Interdisciplinary announcement and may be filled in one of the following series: 0850 (Electrical Engineer), 0854 (Computer Engineer), 0855 (Electronics Engineer), 0858 (Biomedical Engineer).
This position is located at the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of the Center Director (OCD) located in Silver Spring, MD.
This vacancy is also being announced concurrently with vacancy announcement FDA-CDRH-17-MP-10012103AN under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.
**This announcement has been extended and will now close on 10/2/2017**
Additional selections may be made within the same geographical area FDA wide.
Summary
Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.
This is an Interdisciplinary announcement and may be filled in one of the following series: 0850 (Electrical Engineer), 0854 (Computer Engineer), 0855 (Electronics Engineer), 0858 (Biomedical Engineer).
This position is located at the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of the Center Director (OCD) located in Silver Spring, MD.
This vacancy is also being announced concurrently with vacancy announcement FDA-CDRH-17-MP-10012103AN under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.
**This announcement has been extended and will now close on 10/2/2017**
Additional selections may be made within the same geographical area FDA wide.
As an Interdisciplinary Engineer in the Office of the Center Director (OCD), you will be responsible for:
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
Developing 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.
Participating as a subject matter expert, when necessary, in premarket and postmarket review of digital health products.
Coordinating and providing support to FDA work groups establishing digital health regulations, procedures, and programs having national or international impact.
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.
Drafting responses to correspondence from within and outside the agency concerning digital health products.
Developing and delivering training on new digital health technology regulations, procedures, and programs to key stakeholder audiences.
Only experience gained by closing date will be considered.
One-year probationary period may be required
Conditions of Employment:
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.
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.
Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
Pre-employment physical required: No
Drug testing required: No
License required: No
Mobility agreement required: No
Immunization required: No
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.
Bargaining Unit Position: Yes
All qualification requirements must be met by the closing of the announcement.
Please be advised that this position will be subject to FDA's strict prohibited financial interest regulation and therefore, may require the incumbent of this position to divest of certain financial interests. Applicants are strongly advised to seek additional information on this requirement from the FDA hiring official before accepting this position.
Qualifications
In order to qualify for the Interdisciplinary Engineer, 0850/0854/0855/0858-14 level, you must meet the following basic requirement (you must submit a copy of your transcripts) AND specialized experience below.
Basic Requirement:
A. 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)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. (You must submit licensure for confirmation under this provision.)
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.)
Note: An applicant who meets the basic requirements as specified in A or B above, except as noted under B.1., may qualify for positions in any branch of engineering unless selective factors indicate otherwise.
Specialized Experience:
You must have at least one full-time year (12-months) of specialized experience equivalent to at least the GS-13 grade level in the Federal service that included:
Managing all aspects of total product lifecycle (concept and development through maintenance and product retirement) for software and digital health products;
Advising other engineers or scientists concerning software-related medical device and digital health policy;
Analyzing and evaluating policies that impact digital health;
Identifying technology trends and evolving science that may influence digital health technologies, medical device development, evaluation, and regulatory policy; and
Performing software engineering work on digital health products and medical devices.
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.
Education
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.
Veterans' Preference: If you are a veteran with preference eligibility and you are claiming 5-point veterans' preference, you must submit a copy of your DD-214 (Member Copy 4) or an official statement from your command if currently on active duty that certifies you are expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is signed. If you are claiming 10-point veterans' preference, in addition to the DD-214, you must also submit a Standard Form 15 (Application for 10-Point Veteran Preference) and the required supporting documents listed on that form. For more information on veterans' preference see http://www.fedshirevets.gov/.
If you are serving, or have served in the last 5 years (from the close of this announcement) 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.
Career Transition Program: This program applies to Federal service employees whose positions have been deemed surplus or no longer needed, or employees who have been involuntarily separated from a Federal service position within the competitive service. To receive selection priority for this position, you must: 1) meet eligibility criteria for CTAP or ICTAP; 2) be rated well-qualified for the position; and 3) submit the appropriate documentation to support your CTAP or ICTAP eligibility. Well-Qualified includes those applicants whose knowledge, skills, and abilities clearly exceed the minimum qualification requirements for the position. For information on eligibility criteria and required documentation, go to: http://www.opm.gov/rif/employee_guides/career_transition.asp
Males born after 12/31/59 must be registered or exempt from Selective Service (see http://www.sss.gov/).
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 see Agency Contact Info for whom to contact for more info. The decision on granting reasonable accommodation will be made on a case-by-case basis.
For information on disability employment, please visit https://www.opm.gov/policy-data-oversight/disability-employment/
You are encouraged to apply online. If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application.
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
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, a review of your 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 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.
Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Basis of Rating: Category rating procedures will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be assigned to one of 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 Rating Process does not add veteran's preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher). Veteran preference eligibles will receive selection consideration before non-preference eligibles within each quality category.
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.
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.
A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new windowLearn more about federal benefits.
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.
Your Résumé - You are encouraged to use the USAJobs online resume builder to ensure that all required information is in your resume. If you use your own résumé, curriculum vitae, or any other written form you choose, you must provide a detailed description of your job-related qualifications that includes beginning and ending dates with the month and year and hours worked per week for each paid and non-paid work experience job title listed. To view a sample of a resume and what should be included please visit: https://www.usajobs.gov/Help/how-to/account/documents/resume/. Failure to provide the required information may result in an ineligible rating.
Responses to the Assessment Questionnaire
College transcripts (if qualifying all or in part based on your education)
Other Supporting Documents: (Only submit if applicable to you.)
Cover letter
Veterans' Preference documentation (e.g., DD-214 Member Copy 4 showing type of discharge/character of service, SF-15, VA letter, etc.)
CTAP/ICTAP documentation:
A copy of your RIF separation notice, notice of proposed removal for failure to relocate, notice of disability annuity termination, or certification from the National Guard Bureau or Military Department that you are eligible for disability retirement;
A copy of your SF-50 "Notification of Personnel Action'', documenting your RIF separation, noting your positions, grade level, and duty location, and/or Agency certification of inability to place you through RPL, etc.;
A copy of your latest performance appraisal including your rating; and
Any documentation from your agency that shows your current promotion potential.
If you are relying on your education to meet qualification requirements:
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.
To apply for this position, you must complete the occupational questionnaire and submit the documentation specified in the Required Documents section below.
To receive consideration for this position you must submit a complete application (including all required documents) by 11:59 PM (ET) on the closing date of this announcement, which is 10/02/2017.
Instructions for applying to this job:
To begin, click Apply. You must be logged into your USAJOBS account to apply. If you do not have a USAJOBS account, you will need to create one before beginning the application.
After logging into your USAJOBS account, you will be taken to an online application which you must complete in order to apply for the position. *Verify the documents required for your application. Follow the prompts to select your USAJOBS resume and/or other supporting documents. You will have the opportunity to upload additional documents to include in your application.
Complete the online questionnaire, include necessary supporting documents and submit your application using the Submit Application button. Your application package will not be processed unless you click Submit Application.
To verify the status of your application, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and select the More Information link for this position. The Application Status page will display the status of your application, the documentation received and processed, and your responses submitted to the online application. Your uploaded documents may take several hours to clear the virus scan process.
To return to saved application at a later date, log into your USAJOBS account and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete.
* It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date.
By submitting your application, you are certifying the accuracy of the information contained in your application. If you make a false statement in any part of your application, you may not be hired; you may be terminated after you begin work; or, you may be fined or jailed. After making a tentative job offer, we will conduct a suitability/security background investigation.
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
US
Next steps
Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We expect to make a selection within 45 days of the closing date of this announcement. Once this process is completed, you will be notified of your status via e-mail.
You will be required to submit official documentation prior to appointment. The agency will then verify the information provided on your application (i.e., degree, veterans' preference, disability, etc.).
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
Your Résumé - You are encouraged to use the USAJobs online resume builder to ensure that all required information is in your resume. If you use your own résumé, curriculum vitae, or any other written form you choose, you must provide a detailed description of your job-related qualifications that includes beginning and ending dates with the month and year and hours worked per week for each paid and non-paid work experience job title listed. To view a sample of a resume and what should be included please visit: https://www.usajobs.gov/Help/how-to/account/documents/resume/. Failure to provide the required information may result in an ineligible rating.
Responses to the Assessment Questionnaire
College transcripts (if qualifying all or in part based on your education)
Other Supporting Documents: (Only submit if applicable to you.)
Cover letter
Veterans' Preference documentation (e.g., DD-214 Member Copy 4 showing type of discharge/character of service, SF-15, VA letter, etc.)
CTAP/ICTAP documentation:
A copy of your RIF separation notice, notice of proposed removal for failure to relocate, notice of disability annuity termination, or certification from the National Guard Bureau or Military Department that you are eligible for disability retirement;
A copy of your SF-50 "Notification of Personnel Action'', documenting your RIF separation, noting your positions, grade level, and duty location, and/or Agency certification of inability to place you through RPL, etc.;
A copy of your latest performance appraisal including your rating; and
Any documentation from your agency that shows your current promotion potential.
If you are relying on your education to meet qualification requirements:
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.
To apply for this position, you must complete the occupational questionnaire and submit the documentation specified in the Required Documents section below.
To receive consideration for this position you must submit a complete application (including all required documents) by 11:59 PM (ET) on the closing date of this announcement, which is 10/02/2017.
Instructions for applying to this job:
To begin, click Apply. You must be logged into your USAJOBS account to apply. If you do not have a USAJOBS account, you will need to create one before beginning the application.
After logging into your USAJOBS account, you will be taken to an online application which you must complete in order to apply for the position. *Verify the documents required for your application. Follow the prompts to select your USAJOBS resume and/or other supporting documents. You will have the opportunity to upload additional documents to include in your application.
Complete the online questionnaire, include necessary supporting documents and submit your application using the Submit Application button. Your application package will not be processed unless you click Submit Application.
To verify the status of your application, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and select the More Information link for this position. The Application Status page will display the status of your application, the documentation received and processed, and your responses submitted to the online application. Your uploaded documents may take several hours to clear the virus scan process.
To return to saved application at a later date, log into your USAJOBS account and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete.
* It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date.
By submitting your application, you are certifying the accuracy of the information contained in your application. If you make a false statement in any part of your application, you may not be hired; you may be terminated after you begin work; or, you may be fined or jailed. After making a tentative job offer, we will conduct a suitability/security background investigation.
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
US
Next steps
Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We expect to make a selection within 45 days of the closing date of this announcement. Once this process is completed, you will be notified of your status via e-mail.
You will be required to submit official documentation prior to appointment. The agency will then verify the information provided on your application (i.e., degree, veterans' preference, disability, etc.).
Fair and transparent
The Federal hiring process is set up to be fair and transparent. Please read the following guidance.
