Irvine, California, United States
Experienced R&D leader and medical device subject matter expert with over a decade of experience driving product innovation, performance optimization, and cross-functional collaboration. I specialize in medical device development, from concept to commercialization, including FDA-regulated Class II and III devices. My expertise spans product development, verification and validation, manufacturing, and team development. I’m passionate about improving quality of life through innovative solutions and fostering psychological safety within teams. With a strong foundation in engineering and regulatory compliance, I’ve successfully launched cutting-edge technologies, including advanced insulin pumps and cardiac implants. Open to mentoring emerging engineers and advancing transformative projects.
Leading budding and established medical device companies through the following: -- System Design and Development -- Design Test Verification -- Manufacturing Process Validations -- Test System Development -- Regulatory Agency interfacing for Performance and Safety
DeviceAlliance is the only non-profit professional association focused exclusively on promoting the vitality of southern California’s medical device community. We are committed to building lasting relationships, sharing information, and gaining insight into the key issues and opportunities within the medical device industry. For more information please visit us at www.devicealliance.org.
Lecture Topics: - Design Control - Measurement System Analysis
- Lead Systems & Hardware Design Verification for two commercially available products - Lead system-level testing for mobile applications and sensor integrations - Developed and implemented semi- and fully automated systems to improve test activities and reporting - Developed methodologies and processes for device and component reliability - Established certification for IEEE Customer Testing Facility Stage 2 ---------------------------------------------------------------------------- IPO Completion January 30, 2025 raising approximately $229 million. ----------------------------------------------------------------------------