Shawn Ryan

Background

About Shawn Ryan

As a Principal Design Assurance Engineer and Quality Core Team Lead, I provide strategic quality leadership across cross-functional product development teams in the medical device industry. I ensure Design History File (DHF) integrity and regulatory compliance from concept through commercialization, while guiding and mentoring extended Quality work-stream contributors. With deep expertise spanning product development and manufacturing support, I bring a systems-level perspective that drives product and process excellence. I’m well-versed in global regulatory requirements—including ISO 14971, IEC 60601-1, IEC 62366-1, and IEC 81001-5-1—and actively contribute to ongoing efforts to integrate cybersecurity risk assessments into broader safety risk management practices in alignment with evolving standards. My focus is on delivering safe, effective, and reliable medical technologies by ensuring development artifacts are robust, risk-based, and aligned with customer needs, performance requirements, and applicable standards.