About EdgeOne
A Different Kind of Partner
At EdgeOne Medical, we’re proud to stand out. Our mission goes beyond just providing services—we’re here to build lasting relationships and help you bring safe, effective products to market with a team that truly understands your challenges.
Our Journey and Purpose
Founded in 2012 to fill a critical gap in the industry, EdgeOne Medical emerged as a leader in combination product development services. We recognized the industry needed a partner that not only understood the complexities of design verification testing but also understood how those activities were interconnected and interdependent to the regulated device development process: from defining requirements to submission.
Why outsource to someone that you need to teach?
Our StoryWhat Makes Us Different?
Over the past 12 years, we’ve enjoyed watching some of our competitors try to replicate our services but our difference lies in our people, our culture, and our expertise.
While we recognized a gap in the industry, we also had a track record of building teams with a great culture. At EdgeOne Medical we focus on delivering high quality services to our customers, but we also focus on enjoying the journey through our values-based culture. The result is lasting, trusting relationships with our employees, our clients and our partners.
It’s difficult to quantify culture, but we constantly hear feedback from our employees, our customers and even candidates as they go through the interview process that “it’s” different. We like being different!
A Testament of Success
A true testament of our success is how our customers talk about us. One of our best tag lines was actually a call to action coined and used by one of our customers.
While listening to his colleagues discuss a problem they were having on their project, he simply turned to them and said, “Why don’t you EdgeOne it?” And thus was born EdgeOne It! A vote of confidence simply articulated.
Meet the Team Behind EdgeOne Medical
Lilli Zakarija is Co-Founder and President of EdgeOne Medical Inc and has over 25 years of experience in the medical device/combination product 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 (spun out as Baxalta, then acquired by Shire and subsequently Takeda).
Lilli has a Bachelor of Science in Biomedical Engineering and a Master in Engineering Management from Northwestern University, and an Executive MBA from Kellogg School of Management. In addition, Lilli serves on the National Board of Directors for Women in Bio, is an adjunct professor at Northwestern University, a mentor to medical device start-ups in the Chicagoland area and was previously on Board of Advisors for Biomedical Engineering Dept at Northwestern University. And along the way she is raising her 3 kids to be the best version of themselves.
Jim’s vision for a seamless, middle-ground service provider has been instrumental in EdgeOne’s growth. His passion for innovation and commitment to solving industry challenges have helped make EdgeOne a trusted partner for pharma and medtech companies.
Jim McGough is co-founder and a Board Member at EdgeOne Medical Inc. a leading global Device Development and Testing Services firm for the Pharmaceutical Industry. He is also Managing Partner of EdgeOne Venture Partners.
Additionally, he is an eclectic angel investor and board member or advisor in several HealthTech and Big Data/AI ventures. Earlier in his career Jim held various Executive and Intrapreneurial leadership roles at Motorola, Audi, and Citigroup. Jim likes to be on the leading edge of technological innovation - at Audi as Head of Marketing & eBusiness he championed and led the first integration of a smart-phone via Bluetooth so that a call could seamlessly transfer from your device to your vehicle.
Jim has a Master in International Management degree in International Finance from the Thunderbird Global School of Management and has a Bachelor of Arts degree in History from the University of California at Berkeley.
Jerzy Wojcik is Vice President of Quality and Regulatory Affairs Services at EdgeOne Medical Inc., and has over 25 years of industry experience in quality and regulatory affairs at Baxter Healthcare, Avery Dennison Medical (Vancive Medical), Deloitte, Abbott Laboratories and Baxter (Takeda) 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 was an Adjunct Professor in the School of Law at Northwestern University, IL. He is a member of Regulatory Affairs Professional Society (RAPS) and volunteers with Chicago Innovation Mentors (CIM). Jerzy speaks Polish and Spanish.
Scott Ariagno is Vice President of Engineering and Development Services at EdgeOne Medical and has over 20 years in medical device and combination product design, development and manufacturing. His expertise includes development and global launch of of various single-use, disposable medical devices, infusion systems and combination products, strategic/technical development of device platforms and IP development. Throughout his career he has held management roles in engineering including heading device development and external manufacturing at Shire (now Takeda). Scott is a named inventor on over 20 patents and applications.
Scott has Bachelor of Science in Mechanical Engineering from Bradley University and a Master in Engineering Management from Northwestern University.
Brendan Kelly is Senior Director of Quality at EdgeOne Medical and has over 20 years of engineering experience, including 15 years of direct experience in the field of medical devices. His extensive expertise includes EU MDR, FDA CFR Part 820, ISO13485, ISO14971, quality management and regulatory affairs. Throughout his career, Brendanhas led numerous projects focused on enhancing enterprise quality and Quality Management Systems (QMS) both locally and on a corporate scale. His most notable leadership roles involved leading a global transition to EU MDR, multiple mergers and acquisitions, and global strategic initiatives for quality improvement and regulatory compliance.
Brendan's professional qualifications include prestigious certifications from the American Society for Quality (ASQ), including Master Black Belt, Manager of Quality/Organizational Excellence, and Six Sigma Black Belt.
Brendan has a Bachelor of Engineering in Industrial Engineering and Information Systems and a Higher Diploma in Quality Assurance from the University of Galway. He also holds a Post Graduate Diploma in Project Management from the Trinity College Dublin, Ireland.
Dan Weissmueller is Senior Director of Business Development at EdgeOne Medical with over 20 years of experience in drug and medical device development and seasoned professional dedicated to advancing innovative medicines. Dan's extensive background spans analytical development, quality assurance, CMC, and regulatory compliance, equipping him with a comprehensive understanding of the industry landscape which helps clients navigate the complexities of their drug development, ensuring that life-changing and life-saving solutions reach patients efficiently.
Prior to EdgeOne Medical, Dan held several key executive leadership positions at Regis Technologies, including oversight of all quality, regulatory and analytical operations. His leadership and commitment to quality resulted in a culture of compliance that led to sustained growth while maintaining over a decade of positive inspection outcomes and multiple new drug approvals.
Dan earned his M.S. in Regulatory Compliance from Northwestern University and holds a B.S. in Chemistry from Benedictine University. His mission is clear: to empower clients in their quest to improve patient outcomes with reliable and innovative solutions.
Kelly Nienburg is a Sr. Project Manager at EdgeOne Medical with over a decade of experience in the medical device and combination products industry. With a robust background in Quality, Engineering, and Project Management, Kelly has successfully led diverse project teams to troubleshoot challenges and help drive innovative products from concept to market. By building strong partnerships and relationships with our clients, she creates a cohesive team approach that aligns project goals with client needs.
Prior to joining EdgeOne, Kelly has also played a crucial role in helping clients revamp their processes, with a specific focus on Design Controls, ensuring compliance and efficiency throughout product development.
Kelly has a Bachelors of Science in Chemical and Biological Engineering, with a Minor in Biomedical Engineering from Colorado State University.
Michelle Moran is Senior Director of Engineering and Development Services with over 30 years of proven track record in Engineering and Development Services. She brings an exceptional level of expertise in combination product strategy, development, launch, and sustaining engineering. Throughout her career, Michelle has consistently demonstrated her ability for successful program management, technical leadership and quality support with her most notable achievement leading the strategy for BioLife Device.
Having worked with three renowned multinational companies - Baxter, Takeda, and Bausch & Lomb, Michelle brings a wealth of accrued experience. She has over 9 patents and publications and has garnered twelve awards in recognition of her outstanding work and exceptional leadership.
Michelle has a Bachelor of Science in Plastic Engineering from the University of Lowell. Additionally, she possesses two Master of Science degrees - one in Plastic Engineering from the University of Lowell and the other in Manufacturing Management and Leadership from the prestigious Rochester Institute of Technology.
