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Stephanie Summe, Senior Director of Device Development

Ms. Summe leads the Device team of engineers supporting remediation, lifecycle management, and innovation of ongoing design and sustaining engineering activities related to the ApiJect Platform of drug delivery technologies. She establishes design engineering solutions as it relates to customer needs, product requirements, and the development of product designs. Additionally, Ms. Pierle is responsible for developing and maintaining Design History Files, ensuring that performance and quality of ApiJect’s development process complies with quality management systems, regulations, standards, and agency guidelines.

At Pfizer Inc., Ms. Summe held a series of positions with steadily increasing engineering, technical, and managerial responsibilities. Most recently, she was Senior Manager, Global Device Engineering, where she led a team of 10 device engineers focused on the lifecycle and innovation of medical device and combination products. She also partnered with product portfolio leads to develop device portfolio strategies. Ms. Summe was the site subject matter expert for medical device and combination product requirements, responsible for ensuring compliance with site procedures and medical device regulations and standards. Prior to that, she was part of the Technical Professional Development Program at Hospira, providing technical support for parenteral product formulation, related fill-finish issues, and identification of optimization parameters for syringe siliconization processing. A graduate of North Carolina State University with a degree in Biomedical Engineering with a concentration on Biomechanical, Ms. Summe is currently pursuing a Master of Business Administration from the University of North Carolina.

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