An engineer who works with drugs, medical devices, and genetically-modified (GM) foods for the Food and Drug Administration (FDA) tests these products and reviews data to make sure they are safe and effective. For example, a food engineer might look for allergic reactions that could result from eating a type of rice that now has a gene from another organism. A biomedical engineer might oversee a series of trials with lab animals to make sure that a new artificial heart valve is going to be safe and reliable in humans. A pharmaceutical engineer puts a new drug through years of testing and a lengthy evaluation period before it is approved for use. Once a product is FDA-approved, research engineers will then gather and monitor data to make sure that the product is indeed safe and effective, and may also look into ways to improve upon it. Most FDA research engineers have a Master’s or Ph.D. degree in a related field, such as chemical engineering, microbiology, or pharmacology.
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Research Engineer in Action
Dr. Tong-Jen Fu
Title: Research Engineer, Food and Drug Administration
Education: Ph.D., Chemical Engineering, Pennsylvania State University
Dr. Tong-Jen Fu is a research engineer with the Food and Drug Administration (FDA), where she evaluates the allergy tests used for GM foods. She and other researchers are trying to understand exactly what makes substances in food cause allergic reactions.
One of the concerns of GM food is its potential to increase allergies in humans. Many proteins can potentially be an allergenthat is, cause an allergic reaction in some people. Since genetic engineering introduces new proteins into crops, concerns have been raised that unexpected allergies may arise. GM foods could trigger allergies by including proteins already known to cause a reaction, or by introducing completely new allergy-causing proteinssuch as those from bacteriainto the food supply.
Researchers use extensive safety tests to determine whether a genetically modified food is likely to cause an allergic reaction. If any of these tests has a positive reaction, the GM food is not likely to be produced. These tests include checking the DNA against the DNA of known allergens and testing how digestion affects potential allergens.