Food and Drug Administration Interdisciplinary Engineer in Few vacancies Silver Spring, Maryland
Food and Drug Administration
- Few vacancies - Silver Spring, MD
Work Schedule is Full Time - Permanent
Opened Tuesday 7/5/2016 (114 day(s) ago)
** Closes Monday 10/31/2016 (4 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 in the Office of Device Evaluation, you will serve as the senior level reviewer of data in your scientific specialty field in order to determine the safety and efficacy of medical devices. Duties include:
Reviewing scientific data submitted in support of a variety of medical device submissions (e.g. premarket applications, product development protocols, applications for investigational device exemptions, etc.) to determine its accuracy and sufficiency;
Reviewing research protocols used to evaluate medical devices and recommending new or modified methods for testing and data analysis;
Writing and evaluating guidelines concerning data submissions for medical devices and their marketing;
Making presentation to the medical/scientific panel members on the FDA Advisory Committee responsible for the classification and premarket review of medical devices; and
Drafting a variety of reports and summaries on the safety and effectiveness of devices submitted in a premarket approval application
- Not Required
- You must be a U.S. Citizen or National.
- Resume and supporting documents (See How To Apply section)
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, in order to qualify at the GS-12 level, you must possess one year of specialized experience, equivalent to the GS-11 level in the Federal service, analyzing scientific data submitted by other scientists/researchers to provide feedback or advice on methods/procedures utilized; conducting research or briefings on the classification and scientific review of medical device products or other scientific systems/designs; modifying existing guidelines and protocols for scientific testing of medical device products or other scientific systems and designs; and providing information to researchers or scientists on guidelines, scientific, or regulatory requirements related to research on scientific products. In addition, in order to qualify at the GS-13 level, you must possess one year of specialized experience, equivalent to the GS-12 level in the Federal service, reviewing technical or complex data (e.g. related to multi-step processes, combination products, etc.) for scientific/research projects related to the accuracy, safety, or efficacy of a medical device or scientific system/process; providing advice and assistance to scientists in developing scientific and technical policies; reviewing research protocols to evaluate medical device products, scientific projects, or research assignments; and recommending solutions to scientific complaints, research discrepancies, and/or product problems.
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.
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.
Salary Range: $77,490.00 to $119,794.00 / Per Year
Series & Grade: GS-0806, 0830, 0850, 0858, 0893-12/13
Promotion Potential: 13
Supervisory Status: No
Who May Apply: United States Citizens
Control Number: 443663300
Job Announcement Number: PH-NM-16-756516-S8