Summary
Mark Urbin is a Senior Software Quality Assurance Engineer with 13 years of focused experience driving quality and compliance across medical devices, consumer electronics, networking, and cybersecurity. He blends hands-on SQA leadership with regulatory expertise—authoring IEC 62304, ISO 14971, ISO 13485, and 21 CFR Part 11 documentation—and has supported a successful PMA release for an IVD product. Known as a pragmatic troubleshooter and mentor, he’s routinely deployed to resolve the most challenging product and customer issues worldwide and has a history of building automation and analytics (including Python dashboards) to surface strategic defect trends. Comfortable operating cross-functionally with engineering, product, and clinical teams, he pairs an MBA and a graduate certificate in cybersecurity with deep practical experience validating tools and processes. Based in Massachusetts, he brings a rare mix of secure development stewardship and operational rigor that reduces risk while accelerating regulated product delivery.
13 years of coding experience
24 years of employment as a software developer
Graduate Certificate Cybersecurity, Graduate Certificate Cybersecurity at Worcester Polytechnic Institute
BS computer Science, BS computer Science at SUNY New Paltz