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 website.
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.
FDA engineers are located in headquarters (suburban Washington, D.C.) and in FDA facilities throughout the country.