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Description of Position
FDA engineers serve as scientific reviewers of data in a scientific
specialty field to determine the safety and efficacy of medical
devices. Duties consist primarily of evaluating scientific
data, as well as test methods and descriptions of devices
contained in medical device submissions from manufacturers
to the agency. The following are typical duties:
- reviews scientific data related to the different areas of specialty which are submitted in support of a variety of device actions
- reviews technical data submitted in support of the device submissions with respect to accuracy, precision and reliability
- makes presentations to the medical and scientific experts who serve as panel members on the various FDA advisory committees
- reviews research protocols to evaluate medical
devices
- writes and evaluates guidelines concerning
the data required in device actions submitted to the agency
for medical devices and their marketing
- develops, modifies, and evaluates guidelines concerning data required in device actions submitted to the agency for medical devices
- presents reviews, conclusions, opinions and recommendations to appropriate scientific review panel on premarket approval applications, product development protocols, and petitions for reclassification.
Grade (Salary) Levels
The federal General Schedule (GS) grade levels at which
these positions are most commonly filled are GS-7 through
13 at the headquarters level.
For a list of GS-grade salaries, see the Office of Personnel Management Web site.
Qualifications
Basic requirements for all engineering positions include successful
completion of a full 4-year professional engineering curriculum
leading to a bachelor or higher degree in engineering in an
accredited college or university, OR a combination of education
and experience college-level education, training, and/or
technical experience that furnish:
- a thorough knowledge of the physical and
mathematical sciences underlying professional engineering
- a good understanding, both theoretical and
practical, of the engineering sciences and techniques and
their application to one of the branches of engineering.
In addition to the basic qualifications, each grade requires additional amounts of either specialized experience or directly related education.
Geographic Locations
FDA engineers are located in headquarters (suburban Washington,
D.C.) and in FDA facilities throughout the country.
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