Alumni Fellow transitioned from bedside nurse to leadership role at FDA

Donna Engleman’s quest to serve patients took her from the bedside to overseeing allegations of regulatory misconduct at the Food and Drug Administration.

Engleman, a 1988 B.S.N. graduate of the School of Nursing, has been named a 2016 University of Louisville Alumni Fellow, an honor bestowed to prominent graduates who have earned distinction in their careers and have been exemplary ambassadors for the university.

Engleman began her career as a nurse in the intensive care unit at University of Louisville Hospital and is now Chief of the Allegations of Regulatory Misconduct Branch, Office of Compliance, Center for Devices and Radiological Health at the FDA. She oversees the intake, pre-investigational review, triage, and risk prioritization of regulatory misconduct complaints and has initiated numerous patient safety initiatives and designed and instituted risk prioritization criteria currently utilized at the FDA.   

What does it mean to you to be recognized as an Alumni Fellow?

Throughout my nursing career, I’ve tried to make choices that I felt best utilized my skills and abilities to promote patient health. Being selected for this honor recognizes that the decisions I have made have been the best use of my skillset to promote patient health.

Speak about your role with the FDA, what does your job entail?

My role is serving as a subject matter expert for allegations of regulatory misconduct, which are correspondence or situations where any entity can be of the belief that a manufacturer is not complying with their regulatory obligations in terms of medical device marketing. 

How does having a BSN prepare you for a job like that?

Throughout my career, my critical thinking skills have continued to develop and that’s one of the key takeaways from my UofL nursing education; building the foundation for critical thinking and functioning professionally as a scientist. Those skills have best prepared me for the work that I do now.

You started your nursing career as a bedside nurse at University of Louisville Hospital. How has your career transitioned?

From nursing school through my nursing career at University of Louisville Hospital, I was looking for how I could best serve patients. Being a nurse at University Hospital, those bedside experiences were some of the best because it gave me real world experiences with patients, whether it was medical conditions, exposure to technology or complex protocol for patient care. It also left me wondering how do we know that’s the best way to serve our patients and I think that is how I developed the interest in research, to understand all that I could about the care that we were providing and whether it was the best care that could be given. During this time, I relocated to the D.C. area with my family. I thought about going back to the hospital setting, but I didn’t feel like that was how I could best serve patients, plus I wanted a new experience.

What messages do you hope to convey to nursing students?

To remember that we’re all in this profession for the patients. It’s also important to know ourselves and how we can make the best contributions to patient health. Allow yourself to identify your strengths and weaknesses, pay attention to them and position and leverage yourself to where you can make the best contribution.

Donna Engleman will speak to UofL nursing students at 10:30 a.m. Thursday, Oct. 20, about her nursing career and her current position with the FDA. Engleman and other Alumni Fellows will be recognized at the Wilson Wyatt Alumni Awards 6 p.m. Thursday at the Galt House Hotel. Attendees may register here. 

Oct. 19, 2016