Lilli Zakarija
Bringing Clarity, Compliance and Speed to Combination Product Programs | Values Based Leader | Educator & Mentor to Next Generation of MedTech/BioTech Innovators
- Role
- President at Edgeone Medical
- Location
- Chicago, IL, US
- LinkedIn followers
- 500 followers
About Lilli Zakarija
Tired of trying to figure out how to staff your engineering organization, insource vs outsourcing, without compromising quality?We help medical device and combination product manufacturers that are grappling with the following issues:* Internal engineering & testing resources stretched to support device development programs* Project timelines and progress suffering while temporary resources are recruited and trained* Key experienced engineers getting caught up in working on low value project issues * Not enough time to complete test method validations prior to initiation of design verification testing* Trouble finding an experienced, reliable external partner that understands medical device development process and how/when to incorporate it into the drug/biologic development programAs a versatile Medical Device executive, I dealt with these issues every day. Having been on the front lines of leading an engineering and testing R&D organization, I found myself wondering if other executives were dealing with the same issues. Having led the device engineering team that supported the entire BioScience business unit within Baxter (now Baxalta) and the need to continually balance competing priorities, it was apparent to me that there was a gap in providers that could support design verification testing for medical device as well as combination products. Essentially, these core problems help shape EdgeOne Medical into specializing in this area. If you’re open to a different perspective that you might not have access to now, then perhaps it might make sense for us to have a private conversation to learn a little more about your situation. Medical Device Testing Development | Product or Platform Strategy | ISO 13485 Compliance | Design Verification Testing | Regulatory Filing | Test Method Validation
Experience
President
Sep 2012 — Present · Chicago, IL, US
President of EdgeOne Medical, a medical device service organization focused on providing comprehensive product performance testing, quality and regulatory services in support of device development and product life cycle management. ISO 13485 certified.
Education
Northwestern University
Bachelor, Biomedical Engineering
1990 — 1995
Northwestern University
Masters, Engineering Management
1999 — 2001
Northwestern University - Kellogg School of Management
EMBA
2008 — 2010
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