SENIOR SOFTWARE ENGINEER I
Joined: June 15, 2026
In 4 years of FDA-regulated device software I have carried a 510(k) AI-enabled SaMD to clearance and now support De Novo and 510(k) submissions for AI/ML SaMD at Innolitics. I led the PCCP implementation inside the QMS for controlled post-market model updates, and wrote the requirements, architecture, ISO 14971 risk management, and V&V documentation under IEC 62304 and ISO 13485. At Innolitics I work on De Novo and 510(k) submissions for AI/ML SaMD, including retrieval-augmented and foundation-model systems, from Pre-Sub strategy through verification and validation. I hold a bioengineering degree from the University of Colorado Denver.
I have worked in the medical device industry for approximately five years, gaining experience in both large MedTech organizations and startup environments. Throughout my career, I have contributed to the development of FDA-regulated medical devices across the full product lifecycle, including software development, AI and machine learning applications, regulatory strategy, verification and validation, risk management, and 510(k) submissions.
Over the course of my career, I have worked on products at various stages of development, from early concepts to regulatory submission. This experience has given me an appreciation for the balance between technical innovation, product quality, and regulatory compliance.
One of the biggest lessons I've learned is that successful medical device development is a team effort. Whether working with engineers, clinicians, quality, or regulatory professionals, clear communication and collaboration are critical to getting products to market. I enjoy working with cross-functional teams to solve problems and deliver products that can make a real impact on patient care.