Job details
Salary $81,216 - $105,579 a year job type full-time
Full job description
Duties
This position(s) is located in the food and drug administration (fda), center for devices and radiological heath (cdrh), office of product quality and assessment (opeq)As a scientific reviewer (staff fellow) in opeq, you will:
Review scientific data submitted in support of a variety of medical device submissions to determine the safety and effectiveness.
Review data in the field of general engineering, summarizes it and makes recommendation concerning the data, also provides leadership and guidance in general engineering to other supporting level scientists.
Provide scientific information and consultation to industry, academic, and private laboratory scientists conducting research on the safety and effectiveness of materials used in the manufacture of medical device products or other scientific systems.
Utilize knowledge and experience to inform scientific and regulatory decisions regarding the safety and effectiveness of new and existing in medical devices as an integral member of multidisciplinary review teams;
Prepare oral and written communications of review recommendations; effectively communicate within fda, with device manufacturers, and with other public health stakeholders;
Advance knowledge and keep abreast of latest scientific trends, technologies, and techniques related to areas of expertise.
Requirements
Conditions of employment
Public filer financial disclosure statement required, see the additional information section for details!
Males born on, or after, december 31st 1959 must be registered with the selective service system or have an approved exemptionVisit www.sss.gov for more info.
Background and/or security investigation required, see the additional information section for details!
Prohibited financial interest restrictions apply, see the additional information section for details!
Veterans preference does not apply to positions, such as this one, advertised under title 42-g hiring regulations.
Qualifications
Basic qualification requirements:
Degree: engineeringTo 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
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.
1Professional 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 ricoAbsent 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 registrationFor 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.
2Written 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.
3Specified 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 aThe courses must be fully acceptable toward meeting the requirements of an engineering program as described in paragraph a.
4Related 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 guidanceOrdinarily 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.
Minimum qualifications for rg-00 (equivalent to gs-13):
You must possess one year of experience, equivalent to the gs-12 level in the federal service, experience includes: advising on compliance and/or regulatory policy developments; preparing and presenting briefings to senior level management and recommending program enhancements; and developing, modifying, and/or evaluating guidelines concerning data required in products such as medical devices and/or radiological products.
Desirable education: a doctoral-level degree from an accredited institution of higher learning, such as a ph.dOr d.v.m., or other research doctoral-degree widely recognized in u.sAcademe as equivalent to a ph.d.
Education
You must submit an official transcript, unofficial transcript or a list of courses to include, grade earned, completion date(s) and quarter semester hours earned.
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.sEducation program; or full credit has been given for the courses at a u.sAccredited college or universityFor further information, visit the u.sDepartment of education website for foreign education evaluation.
Additional information
Additional conditions of employment:
Security and background requirements: this position requires a security clearanceIf not previously completed, a background security investigation will be required for all appointeesAppointment will be subject to the applicant`s successful completion of a background security investigation and favorable adjudication of a secret clearanceFailure to successfully meet these requirements may be grounds for appropriate personnel actionApplicants are also advised that all information concerning qualification is subject to investigationFalse representation may be grounds for non-selection and/or appropriate disciplinary actionFailure to obtain and maintain the required level of clearance may result in the withdrawal of a position offer or removal.
Political appointees: if you are serving, or have served in the last 5 years (from 01/19/2018) 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 employmentYou 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 listedIf you have served or are currently serving, you must provide a copy of your sf-50, notification of personnel action, documenting this appointmentIn addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaireSee the opm page political appointees faq for more.
E-verify: the u.sDepartment of health and human services is an e-verify participantIf 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` systemFederal 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.
Financial disclosure statement may be requiredFda inspires public confidence by maintaining high ethical principles, and all federal government employees are subject to the conflict of interest statutes and regulations, including the standards of ethical conduct, that govern activities with outside organizations and reporting financial holdingsCertain positions within the fda are subject to strict restrictions on financial holdings (fda regulated financial holdings)The ethics in government act, pl 95-521 also requires the applicant selected for this position to submit a public financial disclosure report, oge-278, prior to assuming this position, annually, and upon termination of employmentTo determine how this position is affected, applicants are advised to seek additional information during the interview process from the ethics and integrity staff, division management programs at (301) 796-8435 prior to accepting such a position.
Prohibited financial interests restrictions apply: employees designated as public or confidential filers, and their spouse or minor children, may not hold financial interests in fda significantly regulated organizations.
Relocation and travel expense reimbursement: no
Bargaining unit: yes/3591/nteu
Benefits
A career with the u.sGovernment provides employees with a comprehensive benefits packageAs a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewardingOpens 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 intermittentContact 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 (at 11:59 pm et on 09/23/2022, a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for federal employment, and then whether or not you are qualified for this particular positionSee the usajobs help article ` what is the difference between eligibility and qualifications?` for more...
Qualification determinations will be based on the information provided in your application and the requirements of the positionPlease follow all instructions carefullyErrors or omissions may affect your eligibility.
Structured interviews; applicants 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.
To preview the assessment questionnaire, click this link: https://apply.usastaffing.gov/viewquestionnaire/11540063
Benefits
A career with the u.sGovernment provides employees with a comprehensive benefits packageAs a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewardingOpens 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 intermittentContact the hiring agency for more information on the specific benefits offered.
Required documents
As a new or existing federal employee, you and your family may have access to a range of benefitsYour benefits depend on the type of position you have - whether you`re a permanent, part-time, temporary or an intermittent employeeYou may be eligible for the following benefits, however, check with your agency to make sure you`re eligible under their policies.
The following documents are required:
Resume
Transcript
`required` means that you must submit these documents in order for your application to be considered completeIf you fail to provide one of these documents, your application may not be considered.
The following documents are accepted:
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
`accepted` means that you may optionally include the documents listed above in your application, if applicable to youThese documents are optional because they are not applicable to all applicants or are not used to determine your qualifications.
If you have questions about the documentation requirements, please reference the following support articles:
How to understand the required documents for a job announcement (usajobs)
What types of documents might i need to submit? (usajobs)
Submitting documents with your application (application manager help site)
You may also contact the fda applicant help desk and reference vin# 11540063The help desk contact info is listed on this announcement.
If you are relying on your education to meet qualification requirements:
Education must be accredited by an accrediting institution recognized by the u.sDepartment of education in order for it to be credited towards qualificationsTherefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the u.sDepartment 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.
Apply Now
You must complete the assessment questionnaire and submit all documentation specified in the required documents section belowTo receive consideration for this position you must submit your complete application by 11:59 pm eastern time on the closing date of this announcement 09/23/2022
You must have a login.gov-enabled usajobs account to apply for jobs with the u.sGovernmentBefore you can apply, you must be signed in to your usajobs accountIf you need assistance with any part of the application process, please visit the following support links:
Usajobs - how to - searching & applying for jobs, managing your account, & more!
Applicant help site - submitting an application, attaching documents, and more!
Apply Now for federal jobs - youtube tutorial by opm
What should i include in my resume? (usajobs)
You are encouraged to apply onlineApplying online will allow you to review and track the status of your application and receive status notificationsHowever, if you are not able to apply online due to extenuating life circumstances or disability, t his agency provides reasonable accommodations on a case-by-case basisIf you need a reasonable accommodation for any part of the application and hiring process, please contact the fda applicant help desk at (888) 478-4340; tty/tdd: (800) 877-8339; or by email quickquestions@fda.gov(in your e-mail request, please replace the blank line with the vacancy identification number, vin, for this job, which is: 11540063D ecisions for granting a reasonable accommodation will be made on a case-by-case basisThe applicant help desk operates between the hours of 7am to 6pm eastern time, monday through friday (except government holidays).
Agency contact information
Fda applicant help desk
Phone
888-478-4340
Email
Quickquestions@fda.gov
Address
Fda center for devices and radiological health
10903 new hampshire ave
Silver spring, md 20993
Us
Next steps
Federal agencies may request information regarding the vaccination status of selected applicants for the purposes of implementing other workplace safety protocols, such as protocols related to masking, physical distancing, testing, travel, and quarantine.
Once the online questionnaire is received you will receive an acknowledgement email that your submission was successfulThe most highly qualified candidates will be referred to the hiring manager for further consideration and possible interviewWe will strive to make a selection within 120 days of the closing date of this announcementYou will be notified of the outcome by e-mail using the e-mail address on file in the application manager system, or by postal mail if no email address was provided by you during the application process.
Fair and transparent
The federal hiring process is setup to be fair and transparentPlease read the following guidance.
Equal employment opportunity (eeo) policy
Reasonable accommodation policy
Financial suitability
Selective service
New employee probationary period
Signature and false statements
Privacy act
Social security number request
Required documents
The following documents are required:
Resume
Transcript
`required` means that you must submit these documents in order for your application to be considered completeIf you fail to provide one of these documents, your application may not be considered.
The following documents are accepted:
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
`accepted` means that you may optionally include the documents listed above in your application, if applicable to youThese documents are optional because they are not applicable to all applicants or are not used to determine your qualifications.
If you have questions about the documentation requirements, please reference the following support articles:
How to understand the required documents for a job announcement (usajobs)
What types of documents might i need to submit? (usajobs)
Submitting documents with your application (application manager help site)
You may also contact the fda applicant help desk and reference vin# 11540063The help desk contact info is listed on this announcement.
If you are relying on your education to meet qualification requirements:
Education must be accredited by an accrediting institution recognized by the u.sDepartment of education in order for it to be credited towards qualificationsTherefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the u.sDepartment 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.
Help
This job is open to
The public
U.sCitizens, nationals or those who owe allegiance to the u.s.
Clarification from the agency
This is an open continuous announcement and will remain open until september 23, 2022There will be subsequent cut-off dates at the end of each monthly periodThis position will be filled through fda`s staff fellowship programThe appointment is an excepted service appointment not to exceed two years with opportunities for renewalNote: the salary listed is at the base levelThe geographic locality pay will be determined at the time of selection.
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