Known information
- Has 15+ years of experience in the medical device industry
- Background includes R&D new product development and sustaining engineering, design assurance engineering, extended quality team management, overall quality system ownership and implementation, and audits
- Helped commercially launch and maintain several Class II and III devices
- Has overseen multiple FDA and EU notified body, supplier, and internal audits
- Held quality management positions at Medtronic and Boston Scientific before co-founding Enzyme
- Holds an MBA from Babson College and a BS in Engineering from Olin College
- Is an ASQ Certified Biomedical Auditor
- Is RAPS Regulatory Affairs Certified (RAC)
About Enzyme
Enzyme is a healthcare IT company based in San Francisco, offering a 21 CFR Part 11 compliant quality management system (QMS) and consulting services to aid life science companies in FDA approval and compliance.