Jared is a 14 year veteran of the medical device and biopharma industries, with a background in product management, medical device software, design assurance and regulatory strategy. His experience ranges from leading spinal cord stimulator programs at St. Jude Neuromodulation (now Abbott), to the UI/UX for the first hybrid closed loop insulin pump at Medtronic Diabetes, to the regulatory strategy for numerous combination drug-device products, including Amgen's Neulasta Onpro and Repatha Pushtronex. Prior to his experience in the life sciences he trained and worked as a software engineer.
He holds a BA from the University of Colorado, an MS in Medical Device Engineering from USC, and a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).
Jacob is a 14 year veteran of the medical device industry, with a background in quality management, design assurance, and audit planning. He has helped commercially launch several Class II and III devices and has overseen multiple FDA and EU notified body audits. Prior to co-founding Enzyme he held quality management positions at Medtronic and Boston Scientific.
Jacob has an MBA from Babson College and a BS in Engineering from Olin College.
Additionally he has achieved several professional certifications in the life sciences, and is an ASQ Certified Biomedical Auditor and RAPS Regulatory Affairs Certified (US).
Mike comes from a sales leadership background with 9 years of experience in leading high performance sales teams across many verticals in the SaaS industry, including Quality Management and SaMD. Mike and his wife currently live and work in Austin, TX.
Brian is an experienced medical device and biopharma industry professional, with a background in medical device product development process, design assurance and systems engineering. He has been responsible for successfully launching Class II & III devices and Drug-Device Combination products. Prior to joining Enzyme he was a consultant to the biopharma industry.
Julien graduated in 2006 from Ecole Polytechnique de Montreal with a B.S. in Software Engineering.
He worked as a Development Architect for a major software vendor before founding his consulting business.
Since then, he continues to build scalable enterprise software with a focus on user interactions and quality.
Lauren comes from a customer success and operations background with 5 years of experience in leading teams in highly regulated SaaS and CPG industries. She currently lives and works in Concord, CA, and during her free time she works with Underdog Animal Rescue to rescue and foster dogs.
Stephen has worked in the medical device industry for 14 years. He has a background in Quality Management, IT, and Project Management. Stephen holds a BA from University of California, Irvine and has achieved professional certifications, including ASQ CMQ/OE and PMI PMP.
Tatiana believes in the power of technology to do good for the people and the world, that is why she enjoys working in the health tech space. Prior to that she was working as a project and program manager for various Silicon Valley start-ups and co-founded one.
Software and DevOps engineer with ~20 years experience in web app development and infrastructure management, Todd brings a hybrid perspective through his familiarity with contemporary development and security practices, bridged with SaMD (ISO 62304) lifecycle, quality, process and risk management.
Katie is a medical device and pharmaceutical professional with a background in product development for drug-delivery systems, endoscopic surgical equipment, and interventional oncology devices. She assists Enzyme clients with design control, risk management, and process development activities for medical devices, combination products, and SaMD products.
A Quality Manager with 8 years of experience in the medical device industry, Michelle has a background in post-market processes and quality systems implementation. In addition to her work in Enzyme Professional Services, she engages with Enzyme customers on an ongoing basis through her work in Enzyme Customer Success.
Rowena has vast experience testing various types of software throughout her testing career and is very much adept in the Software Development Life Cycle. She is also a certified Software tester by the International Software Testing Qualifications Board (ISTQB).
Manasi has over 13 years of experience in the medical device industry designing and executing clinical and product education to customers, patients and physicians. She holds a masters in Biomedical Engineering from Cornell University and an undergraduate degree in Computer Engineering from University of Ottawa.
James has 12+ years experience as a full-stack engineer. He has solved complex problems across many industries in both private and public sectors. When not writing code he occupies his time doing various activities with his family and hopes that one day a boat will be involved.
IB is a software engineer with experience in the entire life-cycle of creating and maintaining software applications. She believes technology should be used to make people’s lives easier and more efficient and is passionate about creating user-friendly software solutions that solve real-world problems.
Rafael has been building quality systems for over 13 years with a variety of technologies in different domains. He is passionate about delivering great user experience with simple and performant software. Before Enzyme, he had his own business to help people make a living through programming skills.
Bart is an experienced software engineer with almost 20 years of hands-on experience in software development, software architecting and dev team management. In his free time he plays soccer and works on his open source project - Hologram (full stack isomorphic Elixir web framework). He is based in Warsaw, Poland.
João has been working as a software engineer for more than 10 years in many different domains, companies and countries. He also has more than 5 years of experience as a CEO of a real estate and construction company which, at the time, had more than 50 employees.
Sam has been a software developer since 2015, working in a variety of tech stacks and industries. He is passionate about education, testing, and writing about himself in the third person. Sam believes tech should be about people first, forever, and always. He lives in Cleveland, Ohio. Outside of work, he loves to cook and make/listen to/talk about music.
Ryan has been in software quality assurance for just over 3 years with a background in medical devices. Born and raised in Oakland, CA, the town forever holds a special place in his heart. To unwind, he loves yoga or listening to indie music. Also carries a passion for camping, hunting, hiking and everything outdoors.
Enzyme has received ISO 9001:2015 certification for its Quality Management System as it applies to the eQMS product. ISO 9001 is a standard that sets out the quality management system requirements to help ensure that products and services consistently meet customer's requirements, and quality is consistently improved.