About

I am a seasoned leader in Software as a Medical Device (SaMD) and software engineering, with over three decades of experience transforming innovative ideas into market-ready products. I have a proven track record of building and leading high-performing teams, specializing in navigating the intersection of technology, quality, and regulatory compliance to deliver exceptional results.

As the VP of Quality & Product Development at Lumos Labs Medical, I led the journey from concept to FDA clearance for a groundbreaking SaMD digital therapeutic. I built the company’s Quality Management System (QMS) from the ground up, created a comprehensive set of Standard Operating Procedures (SOPs), and successfully submitted a 510(k) application via the FDA’s eSTAR process. My expertise spans critical medical device standards and regulations, including 21 CFR 820, ISO 13485, IEC 62304, ISO 14971, and HIPAA compliance. I also led the design, development, and deployment of software for a multi-year clinical study.

Throughout my career, I’ve delivered innovations that have shaped industries. I developed software for the first-ever body motion measurement devices for doctors, enabling orthopedic surgeons to diagnose knee and spine injuries. I also created the first computer-aided surgical tool to assist with anterior cruciate ligament (ACL) replacements, pioneering advancements in medical technology that continue to impact patient care.

Beyond my work in medical devices, my accomplishments span industries. As a co-founder of successful startups and through leadership roles at companies like Lumos Labs Medical, I’ve spearheaded the development of IoT devices, robotic automation software, and the first SaaS-based golf equipment fitting system. My work has reached millions of users globally, with innovative tools in healthcare, travel, entertainment, and more.

I am passionate about empowering teams through coaching, mentorship, and fostering alignment across executive and engineering functions. My leadership philosophy prioritizes clarity, focus, and collaboration, ensuring that projects deliver measurable value.

When I’m not consulting, I enjoy sailing, wing foiling, and spending time on Cape Cod. My personal and professional ethos is rooted in the concept of Sisu—quiet strength, resilience, and determination in the face of challenges.