Has an immediate impact on the safety of food, drug, and medical device industries and assures the comprehensive evaluation of medical devices and radiation emitting appliances.
Performs a variety of scientific testing of FDA regulated products to ensure FDA safety regulations are met.
Conducts engineering analysis for the Government-Wide Quality Assurance Program for medical products at the FDA’s only field laboratory providing this analysis.
ORA Engineers Add Value By:
Providing critical analyses of a full gamut of medical devices which range in complexity from thermometers, optical lenses, and surgical and examination gloves, to apnea monitors, infusion pumps, and diagnostic x-ray equipment. Violative findings provide the foundation for compliance actions which aim to limit the exposure of the public to potentially unsafe or ineffective medical devices.
Reviewing investigational reports and related compliance documentation tied to Agency regulations and Federal laws.
Conducting and assisting in inspections of manufacturers of medical devices and electronic products.
Interpreting and evaluating analytical results to determine validity and scientific significance; writing reports that state results and conclusions that document the nature of any regulatory violations.
Responsibilities
Responsible for analyzing difficult, novel and complex samples which require development or modification of methods.
Performs analyses in the following: (1) full range of commodities regulated by FDA; (2) a broad product area, i.e., foods, drugs, medical devices, mechanical, electronic products, and biomedical, or (3) a combination of these areas.
Determines the general approach necessary to obtain requested information, taking into consideration requirements established by the Agency regulations and Federal laws.
Provides training for less experienced scientists on the precedents, analytical methods and instrumentation related to the particular technical aspects of this position.
Accompanies agency investigators on inspections as a technical advisor.
Winchester Engineering and Analytical Center
Welcome to FDA's Winchester Engineering and Analytical Center (WEAC), located just north of Boston in Winchester, MA. The WEAC laboratory provides specialized analytical services in engineering and medical devices and is FDA's only field lab providing radionuclide analyses. The work at the WEAC facility involves comprehensive evaluation of medical devices and radiation emitting appliances. WEAC is the primary field laboratory upon which CDRH relies for analytical services. All engineering analyses for the GWQAP analytical program are performed at WEAC. In addition to the specialized analytical procedures for radionuclides in foods and radiopharmaceuticals, WEAC performs chemical and microbiological testing.
WEAC Mission
The Winchester Engineering and Analytical Center (WEAC) is a team of highly motivated professional scientists, engineers, and associated staff dedicated to protect the public health through efficient, high quality regulatory analyses, research, inspections, and product standards activities. The focus of these efforts are the engineering, biological, and chemical hazards associated with medical devices, electronic products, radionuclides, and radiopharmaceuticals. The results of WEAC's activities play an integral part in FDA's mission to prevent or limit exposure of the public to unsafe or ineffective devices, drugs, and foods.
Travel Required
25% or less - You may be expected to travel for this position.
Conditions of Employment
This position may be subject to completion of a 1-year probationary period (unless you have already satisfied this obligation).
Citizenship Requirement: You must be a U.S. Citizen or U.S. National to be considered for this advertisement. Foreign nationals or legal permanent residents are not eligible for consideration.
Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
If you were born male, after, December 31st 1959, you must be registered with the Selective Service System, or have an approved exemption. Learn more at www.SSS.gov.
Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities. Your application may be shown to multiple hiring offices.
You may be asked to provide additional information at a later time. All interviews requests and selection decisions are at the full discretion of the hiring office.
Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
Qualifications
BASIC QUALIFICATIONS: In order be eligible for the position of General Engineer, (GS-0801-12), you must meet the following requirements by the closing date of the announcement.
Individual Occupational Requirements Basic Requirements: A. Degree: 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. See details at https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0800/files/all-professional-engineering-positions-0800.pdf
MINIMUM QUALIFICATIONS REQUIREMENTS: You must possess one year (52-weeks) of specialized experience, equivalent to at least the next lower grade level (GS-11) in the Federal service. Such experience includes: applying engineering principles to evaluating products/devices for safety and efficacy, solving engineering problems, determining the accuracy, precision, and/or reliability of proposed medical devices and/or radiological products, collaborating with other engineers and scientists on a wide range of scientific and regulatory issues, reviewing scientific data and determining project technical needs related to medical devices and/or radiological products.
There is no education substitution at the GS-12 level.
NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process.
To return to an incomplete application, 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.
IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume.
All qualification requirements must be met by 11:59 pm (Eastern Time) on 05/26/2020. 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.
Be sure that any files you upload as supporting documentation are free of security or compression features which render such documents unreadable to our system.
Education
(See Individual Occupational Requirements above for education requirements.)You MUST submit a transcript which includes a list of courses, grades, completion dates, and quarter or semester hours earned 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 more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.
Internal Number: 568658500
About FDA Office of Regulatory Affairs - WEAC Branch
US Food and Drug Administration (FDA)
The HHS Food and Drug Administration (FDA) has been recognized as one of the Federal Government's best places to work. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
Office of Regulatory Affairs (ORA)
The Office of Regulatory Affairs, which includes virtually all the field offices of FDA as well as a significant presence in the Washington DC Metropolitan area, serves as the traditional eyes and ears of the agency through its network of investigators and laboratory analysts. ORA works closely with each of the FDA Centers and with other components of the agency to enforce the laws that protect and advance the public health. ORA protects consumers by maximizing compliance of FDA-regulated products and minimizing risk associated with those products. More than 5,000 ORA professionals work in a range of program areas and locations in 227 offices and 13 laboratories throughout the United States every day to maximize... compliance of regulated products and to minimize public health risk. ORA regulates more than 135,000 business establishments that annually produce, warehouse, import, and transport $1 trillion worth of consumer goods.
Welcome to FDA's Winchester Engineering and Analytical Center (WEAC), located just north of Boston in Winchester, MA. The WEAC laboratory provides specialized analytical services in engineering and medical devices and is FDA's only field lab providing radionuclide analyses. The work at the WEAC facility involves comprehensive evaluation of medical devices and radiation emitting appliances. WEAC is the primary field laboratory upon which CDRH relies for analytical services. All engineering analyses for the GWQAP analytical program are performed at WEAC. In addition to the specialized analytical procedures for radionuclides in foods and radiopharmaceuticals, WEAC performs chemical and microbiological testing.
WEAC Mission
The Winchester Engineering and Analytical Center (WEAC) is a team of highly motivated professional scientists, engineers, and associated staff dedicated to protect the public health through efficient, high quality regulatory analyses, research, inspections, and product standards activities. The focus of these efforts are the engineering, biological, and chemical hazards associated with medical devices, electronic products, radionuclides, and radiopharmaceuticals. The results of WEAC's activities play an integral part in FDA's mission to prevent or limit exposure of the public to unsafe or ineffective devices, drugs, and foods.
