Food and Drug Administration Interdisciplinary Scientist in Silver Spring, Maryland
Food and Drug Administration
Few vacancies in the following location:
- Silver Spring, MD
Work Schedule is Full Time - Permanent
Opened Monday 10/17/2016 (3 day(s) ago)
** Closes Friday 10/28/2016 (8 day(s) away)
The Food and Drug Administration - Protecting and Promoting YourHealth
Help protect public health by joining the FDA's Center for Devices & Radiological Health (CDRH). From reviewing applications for innovative medical devices to educating industry on relevant policies and regulations to providing accurate, science-based health information to the public, CDRH is at the forefront in ensuring the safety, efficacy, and security of the medical devices and radiation-emitting products that millions of Americans use daily.
This position is located in the Center for Devices and Radiological Health (CDRH), Office of Device Evaluation in Silver Spring, MD.
One or more positions may be filled using this vacancy announcement.
As a Scientist for the Office of Device Evaluation, you will be responsible for:
- Reviewing a variety of medical device actions, such as premarket notifications of new medical devices (510(k) submissions), premarket approval applications (PMAs), product development protocols (PDPs, investigational device exemptions (IDEs), etc.
- Evaluating the methods used in obtaining scientific results to determine their validity and completeness
- Analyzing scientific and clinical data and information gathered during inspections and investigations to detect regulatory violations
- Presenting reviews, conclusions, opinions, and recommendations to appropriate scientific review panels
- Providing scientific information and consultation to industry, academic and private laboratory scientists concerning the safety and effectiveness of materials used in the manufacturing of medical devices
- Occasional Travel
- Up to 5% domestic travel may be required.
- You must be a U.S. citizen or national to apply for this position.
In order to be qualified for this position, you must meet the basic requirement(s) for the series for which you are applying.
For the GS-0401 Biologist, you must possess one of the following:
A. A Bachelor's or higher degree in biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position* - OR -*
B. A combination of education and experience, which included courses equivalent to a major, as shown in A above, plus additional education or appropriate experience.
For the GS-0403 Microbiologist, you must possess one of the following:
A. A Bachelor's or higher degree in microbiology; or biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent; - OR -
*B. *A combination of education and experience with courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown in A above, plus appropriate experience or additional education.
For the GS-0415 Toxicologist, you must possess the following:
A. A Bachelor's or higher degree in toxicology or an appropriate discipline of the biological, medical, or veterinary sciences that included at least 30 semester hours in chemistry, biochemistry, or physiology, and 12 semester hours in toxicology.
(Please note: Courses in anatomy, chemistry, organic chemistry, biochemistry, biology, histology, and animal, human, microbial, or cellular physiology may be used to meet the 30-semester-hour requirement in chemistry, biochemistry, and physiology. Courses in statistics, bioassay, and test design may also apply to this requirement. Courses in cytology, embryology, cellular or microbial genetics, and biophysics may also be used to meet this requirement in those instances where the course work provided additional insight into the biophysical, biochemical, and physiological relationships involved. Only toxicology courses may be used to meet the requirement for 12 semester hours in toxicology. This may include courses dealing intensively with toxicological search, methods in toxicology, essentials of toxicology, the study and review of toxicological literature, special reading courses, or other toxicologically-oriented subjects.)
For the GS-1320 Chemist, you must possess one of the following:
A. A Bachelor's or higher degree in the physical sciences, life sciences, or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics.* - OR - * B. A combination of education and experience with course work equivalent to a major as shown in A above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education.
In addition to meeting the basic requirement, you must meet the following minimum qualifications for the grade(s) for which you are applying.
A. Have at least one year of specialized experience, equivalent in difficulty and complexity to at least the GS-07 level in the Federal service that include assisting in the review of technical literature or data to determine the safety, efficacy, or degree of risk associated with a medical device or other scientific system; assisting in the review and evaluation of scientific data to determine its completeness or accuracy; performing literature reviews to gather information used for regulatory or scientific purposes; and editing or completing existing reports, memos, presentations, or correspondence related to the results of scientific tests or studies -OR-
B. Have a Master's or 2 years of progressively higher level graduate education leading to a master's or equivalent graduate degree in biology, microbiology, physics, chemistry, or a closely related field that provided the knowledge, skills, and abilities necessary to successfully complete the work of the position -OR-
C. Have a combination of specialized experience as described in A and graduate level education as described in B that, when combined, equal 100% of the total requirement. (Please note that only graduate education in excess of the first 18 semester hours may be used in this calculation.)
A. Have at least one year of specialized experience, equivalent in difficulty and complexity to at least the GS-9 level in the Federal service that include reviewing technical literature or data to determine the safety, efficacy, or degree of risk associated with a medical device or other scientific system; applying existing guidelines or protocols to test scientific products; and drafting reports, memos, presentations, or correspondence related to the results of scientific tests or studies -OR-
B. Have 3 years of progressively higher level graduate education leading to a Ph.D. degree in a related field or possess a Ph.D. or equivalent doctoral degree in biology, microbiology, physics, chemistry, or a closely related field that provided the knowledge, skills, and abilities necessary to successfully complete the work of the position. -OR-
C. Have a combination of specialized experience as described in A and higher graduate level education as described in B that, when combined, equal 100% of the total requirement. (Please note that only graduate education in excess of the first 36 semester hours may be used in this calculation.)
This position requires specific coursework and/or a degree to meet the basic education requirement. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.Your transcript(s) must clearly demonstrate the course(s) listed in the qualification requirement section. If the transcript(s) does not clearly demonstrate this you must submit a copy of the course description and/or other documentation demonstrating that the courses are equivalent. Degree requirements must be met within 30 days of the closing date of this job announcement and your transcript(s) submitted must reflect this.
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. For further information, click on foreign education
All qualification requirements, other than education, must be met by 11:59 PM (Eastern Time) on the closing date of this vacancy announcement. Degree/coursework requirements (if applicable) must be met within 30 days of the close of the announcement. Failure to provide any of the above will result in an ineligible rating. Conditions of Employment:
Security and Background Requirements: If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, 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. 3. Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
Financial disclosure statement may be required.
One-year probationary period may be required.
Travel, transportation, and relocation expenses will be paid: No
Bargaining Unit Position: Yes
Drug Screening Required: No
Recruitment incentives may be authorized: No
Student loan repayment incentive authorized: No
Annual leave for non-federal service authorized: No
Q - Nonsensitive
What To Expect Next
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. You will receive notice via email or by mail (if no email address was provided by you during the application process) once this process is completed (generally 4 - 6 weeks).
The Federal government offers a comprehensive benefits package. Explore the major benefits offered to most Federal employees at http://www.opm.gov/retire/retirejobseekers.asp.
Veterans' Preference:If you are a veteran claiming 5-point veterans' preference, you must submit a copy of your DD-214 (Member Copy 4) or an official statement (including Character of Service) from your command if currently on active duty. 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/ .
Veterans Employment Opportunities Act (VEOA): To be eligible for a VEOA appointment, the veteran must 1) be a preference eligible; or 2) be a veteran separated after 3 or more years of continuous active service performed under honorable conditions. (you must submit a DD214-member copy 4).
Career Transition Assistance Programs: This program applies to Federal workers whose positions have been deemed 'surplus' or no longer needed, or an employee 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'. For information on how to apply and what documents to submit as an CTAP/ICTAP eligible, go to: http://www.opm.gov/rif/employeeguides/careertransition.asp#ictap. Candidates must meet or exceed the Well-Qualified category (85) to be considered as a CTAP/ICTAP eligible.
Noncompetitive Appointment Authorities: The following links contain information on the eligibility requirements to be considered under a noncompetitive appointing authority:
Persons with Disabilities-Schedule A
Special Hiring Authorities for Veterans
Special Hiring Authority for Certain Military Spouses
Other Special Appointment Authorities
Selective Service:The Defense Authorization Act of 1986 requires that all male applicants born after 12/31/59 who are required to register under the Military Selective Service Act, be registered or they are not eligible for appointment to this position. For further information concerning Selective Service requirements, please visit http://www.sss.gov/.
Salary Range: $53,435.00 to $84,044.00 / Per Year
Series & Grade: GS-0401, 0403, 0415, 1320-09/11
Promotion Potential: 13
Supervisory Status: No
Who May Apply: All U.S. Citizens
Control Number: 453258300
Job Announcement Number: HHS-FDA-CDRH-DE-1823694