Sophia V. Kalita is a Biomedical Engineer and Human Factors Consultant with Agilis Consulting Group, LLC. Sophia is experienced in applying human factors principles to the design, evaluation and validation of medical devices and products. Prior to joining Agilis Consulting Group, Sophia worked for a global medical device manufacturer as an R&D engineer where her focus was product design and manufacturing improvement. She advanced to project management where she led cross-functional teams to design and develop valuable medical devices. During this time, Sophia’s accomplishments included managing and ensuring the success of human factors activities.
Sophia completed her Master pf Science in Biomedical Engineering from New Jersey Institute of Technology. Her current role with Agilis allows her to continue to advance her expertise in human factors engineering and exercise her project management skills, which is particularly valuable on large-scale projects to ensure attention to detail and adherence to rigorous schedules. Agilis clients appreciate Sophia’s knowledge of the realities of the medical device industry, passion for excellence, and ability to translate complex human factors and regulatory requirements into real-world solutions that yield efficient regulatory success.