Lilli Zakarija is co-founder and president of EdgeOne Medical, Inc, an ISO 13485-certified medical device testing firm and consultancy focused on supporting combination products through the device development (design control) process. Prior to founding EdgeOne Medical, Lilli developed and led the global device engineering function for Baxter’s BioScience division (now Baxalta) in support of all their combination (biologic & device) products and single-use, disposable medical devices. Ms Zakarija has a BS in Biomedical Engineering and a Masters in Engineering Management from Northwestern University (Evanston, IL, US), and an Executive MBA from Kellogg School of Management (Evanston, IL, US).