Food and Drug Administration Interdisciplinary Engineer in Silver Spring, Maryland
Food and Drug Administration
Many vacancies in the following location:
- Silver Spring, MD
Work Schedule is Full Time - Permanent
Opened Tuesday 7/5/2016 (110 day(s) ago)
** Closes Monday 10/31/2016 (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 of in ensuring the safety, efficacy, and security of the medical devices and radiation-emitting products that millions of Americans use daily.
*Please Note: This announcement is an open continuous announcement, which means that it is open for a longer period of time and certificates will be pulled at various intervals as needed. There is no guarantee if or when a particular opening might become available. *
If you previously applied to this announcement, there is no need to reapply. You are welcome to update your application package, if you so choose, however. You may do so by returning to Application Manager as outlined in the "How To Apply" section of this announcement.
One or more positions may be filled using this vacancy announcement. While most positions are expected to be filled in the Office of Device Evaluation, other Offices within CDRH may use this announcement to fill positions, as well.
As an Engineer 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), establishment inspection reports (EIRs), 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;
- Developing and evaluating guidelines and protocols for testing specific types of devices;
- Presenting reviews, conclusions, opinions, and recommendations to appropriate scientific review panels; and
- Providing scientific information and consultation to industry, academic and private laboratory scientists concerning the safety and effectiveness of medical devices
- Not Required
- You must be a U.S. Citizen or National.
- Resume and supporting documents (See How To Apply section)
You may qualify for this position based on education if you will complete your education by December 31, 2016.
In order to be qualified for this position, you must meet the basic requirement in one of the following ways;
A. Have successfully completed a four year course of study leading to a Bachelor's or higher degree in professional engineering from a school of engineering with at least one curriculum accredited by the Accreditation Board for Engineering and Technology (ABET) as a professional engineering curriculum.* - OR -*
B. Have successfully completed a four year course of study leading a Bachelor's degree in professional engineering that included 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 -
C. Possess a current registration as a professional engineer by any State, the District of Columbia, Guam, or Puerto Rico. - OR -
D. Have passed the Engineer-in-Training (EIT) examination, and in addition, have a combination of education in the field of general engineering and professional engineering experience which totals at least four years. - OR -
E. Have completed at least 60 semester hours of course work in the physical, mathematical and engineering sciences. This course work included differential and integral calculus, as well as courses in at least five of the seven areas listed in response (B). Also, have professional general engineering experience which, when combined with my education as described above, totals at least four years. - OR -
F. Have a Bachelor's or higher degree in engineering technology, chemistry, physics, architecture, computer science, mathematics, hydrology, geology, or another scientific field directly related to engineering. In addition, have at least one year of professional engineering experience acquired under professional engineering supervision and guidance.
In addition, to be qualified at the GS-09 level, you must possess one of the following:
A. One year of specialized experience, equivalent to the GS-07 level in the Federal service, 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. A Master's or higher degree in engineering, physics, or a closely related field that provided the knowledge, skills, and abilities necessary to successfully complete the work of the position. - OR - C. 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.) - OR - D. A Bachelor's degree in engineering with Superior Academic Achievement (SAA) and have one year of professional engineering experience. Professional engineering experience is defined as nonroutine engineering work that required professional knowledge of engineering; professional ability to apply such knowledge to engineering problems; and positive and continuing development of professional knowledge and ability. SAA is defined as: Maintained a grade-point average of "B" (a GPA of 3.0 or higher) for all completed undergraduate courses, or those completed in the last two years of undergraduate study. - OR - 2. Maintained a grade-point average "B+" (a GPA of 3.5 or higher) for all courses in your major field of study, or those courses in your major completed in the last two years of undergraduate study. - OR - 3. Rank in the upper one-third of your class in the college, university, or major subdivision. - OR - 4. Be a member of a national honor (other than freshman honor societies) recognized by the Association of College Honor Societies. Please submit a college transcript(s) showing your grade point average for all four years of undergraduate study, including all transferred courses. NOTE: GPA's are to rounded to one decimal place. For example, 2.95 will round to 3.0 and 2.94 will round to 2.9. If more than 10 percent of your undergraduate course work (credit hours) were taken on a pass/fail or similar basis, your claim must be based on class standing or membership in an honor society. - OR - E. Completed a 5-year program of study of at least 160 semester hours leading to a bachelor's degree in engineering and have one year of professional engineering experience. Professional engineering experience is defined as nonroutine engineering work that required professional knowledge of engineering; professional ability to apply such knowledge to engineering problems; and positive and continuing development of professional knowledge and ability.
In addition, to be qualified at the GS-11 level, you must possess one of the following:
A. One year of specialized experience, equivalent to the GS-09 level in the Federal service, reviewing technical literature or data to determine the safety, efficacy, or degree of risk associated with a medical device or other scientific system; reviewing and evaluating scientific data to determine its completeness or accuracy; 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. Possess a PhD or equivalent degree in in engineering, physics, or a closely related field that provided the knowledge, skills, and abilities necessary to successfully complete the work of the position. - OR - C. Possess 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 36 semester hours may be used in this calculation.)
ARE YOU USING YOUR EDUCATION TO QUALIFY? You MUST provide transcripts or other documentation to support your educational claims. Unless otherwise stated: (1) unofficial transcripts are acceptable, or (2) you may submit a list with all of your courses, grades, semester, year, and credit for the course. All materials must be submitted by the closing date of the announcement.
*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 further information, visit: http://www.ed.gov/about/offices/list/ous/international/usnei/us/edlite-visitus-forrecog.html
Only experience obtained by the closing date of this announcement will be considered.
You may qualify for this position based on education if you will complete your education by December 31, 2016.
Q - Nonsensitive
What To Expect Next
Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. Based upon your score, you may be referred to the hiring official. If your name is referred to the hiring official, you may be contacted directly by that office for a possible interview. 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 number of exceptional benefits to its employees. This link provides an overview of the benefits currently offered to Federal employees. http://www.usajobs.gov/ResourceCenter/Index/Interactive/Benefits#icc
* If you are a veteran with preference eligibility and you are claiming 5-points veterans' preference,* you must submit a copy of your DD-214 or other proof of eligibility. If you are claiming 10-point veterans' preference, you must also submit an SF-15, "Application for 10-Point Veterans' Preference" plus the proof required by that form.For more information on veterans preference see http://www.fedshirevets.gov/job/vetpref/index.aspx
Males born after 12-31-59 must be registered or exempt from Selective Service (see http://www.sss.gov/ ).
Interagency Career Transition Assistance Program (ICTAP): For information on how to apply as an ICTAP eligible see http://www.opm.gov/rif/employeeguides/careertransition.asp#ictap. To be well-qualified and exercise selection priority for this vacancy, displaced Federal employees must be rated at 85 or above on the rating criteria for this position.
Commissioned Corps Officers in the Public Health Service and "qualified" commissioned corps candidates may be considered for internal placement provided they submit a cover letter indicating commissioned corps status, a current resume or curriculum vitae, and provide all other required information specified in the vacancy announcement.
In addition to applying through competitive procedures certain applicants with disabilities may be considered non-competitively under a Schedule A hiring authority. To qualify for employment under Schedule A, an applicant must provide proof of disability and certification of job readiness. As proof of disability and certification of job readiness, applicants may provide records, statement, or other appropriate information issued from a licensed medical professional (e.g., a physician or other medical professional duly certified by a State, the District of Columbia, or a U.S. territory to practice medicine); a licensed vocational rehabilitation specialist (i.e., State or private); or an Federal agency, State agency, or an agency of the District of Columbia or a U.S. territory that issues or provides disability benefits. Proof of disability and certification of job readiness must be included in the application package.
Salary Range: $55,666.00 to $84,044.00 / Per Year
Series & Grade: GS-0806, 0830, 0850, 0858, 0893-09/11
Promotion Potential: 13
Supervisory Status: No
Who May Apply: United States Citizens
Control Number: 443664000
Job Announcement Number: PH-NM-16-756601-S8