Lilli Zakarija is Co-Founder and President of EdgeOne Medical Inc and has over 20 years of experience in the medical device industry. Her expertise includes development and global launch of various single-use, disposable medical devices and combination products, strategic/technical development of device platforms and IP management. Throughout her career she has held management roles in engineering and project management, and prior to founding EdgeOne Medical Lilli established and led the global engineering function supporting all device and combination product related needs for the BioScience division of Baxter Healthcare (now Baxalta a Shire company).
Lilli has a Bachelors of Science in Biomedical Engineering and a Masters in Engineering Management from Northwestern University, and an Executive MBA from Kellogg School of Management. In addition, Lilli serves on the Board of Directors for Women in Bio - Chicago Chapter, Board of Advisors for Biomedical Engineering Dept at Northwestern University, is a Chicago Innovation Mentor (CIM), and is a speaker on device development and combination products.
Joe Braido is a Co-Founder and was responsible for developing EdgeOne Medical's Quality and Regulatory Affairs function. He has over 20 years of experience at Hill-Rom, Abbott Laboratories, Baxter Healthcare, and Eli Lilly. His expertise includes development of regulatory strategies, preparation of FDA submissions (Class II and Class III), CE Marking Technical Files, quality system development, implementation, and remediation with an emphasis in Risk management and Development. Throughout his career he has held management roles in quality and regulatory affairs and most recently was Corporate Director of Quality Risk Management at Baxter.
Mr. Braido has a Bachelor of Science in Biology from Benedictine University. He is a member of the American Society for Quality (ASQ). His professional certifications included RAPS Regulatory Affairs Certification (RAC - US), as well as an ASQ Certified Manager of Operational Excellence (CMQ/OE). He is also speaker for topics in his area of expertise, and is currently an Adjunct Professor at the Northwestern University School of Law. Joe is co-founder of a non-profit organization called Echo Foundation.
Jim McGough is a Co-Founder and has 25 years of experience as an entrepreneur and as an intrapreneur including executive roles at Citibank, Audi, and Motorola. Most recently Jim has served as President/CEO, Board Member, or Advisor for several early stage companies and brings this knowledge and experience to the EdgeOne Medical leadership team. In addition, Mr. McGough is a Principal Advisor at the Larta Institute which administers the Commercial Accelerator Program for NIH Phase 2 grantee life science and digital health companies with high-potential for commercialization.
Mr. McGough has a B.A. in History from the University of California-Berkeley and Master in International Management from the Thunderbird School of Global Management.
Jerzy Wojcik is Director of Quality and Regulatory Affairs, and has over 16 years of industry experience in quality and regulatory affairs at Baxter Healthcare, Avery Dennison Medical (Vancive Medical), Deloitte & Touche, Abbott Laboratories and Baxter BioLife Plasma Services. His expertise includes identification and execution of regulatory activities across all stages of product development and lifecycle management necessary to support Class I, II and III (in both US and EU) medical device, device-biological and device-drug combination products, including wearable sensors and mobile medical applications. Jerzy also has expertise in US distribution and dispensing regulation compliance and US regulatory surveillance for drug, biologics and devices. In addition to medical product regulatory responsibilities, Jerzy also helped develop and implement quality systems and various process quality compliance initiatives.
Mr. Wojcik has a Bachelor of Science in Biology, Medical Technology and Cytotechnology from Augustana College, IL, and is currently an Adjunct Professor in the School of Law at Northwestern University, IL. He is a member of Regulatory Affairs Professional Society (RAPS) and volunteers Chicago Innovation Mentors (CIM) as well as Junior Achievement. Jerzy speaks Polish and Spanish.