San Jose, California, United States
I'm a dynamic and results-driven Software/System Test Engineer with over 12 years of experience in FDA-regulated environments. I specialize in Quality Assurance (QA) and am passionate about improving software applications, tools, robots, and instruments that aid in patient's recovery time and potentially save lives. With my experience leading internal and offshore teams, I excel in cross-functional collaboration, focusing on quality improvements aligned with industry standards such as GCP, Part 11, IEC, ISO 13485, 14971, 9000, and 27000 family, and GAMP5. My expertise also includes developing and deploying robust Quality Management Systems (QMS) and Information Security Management Systems (ISMS) to ensure compliance and security in healthcare fields.
- -Assisting in development and operational planning of a 4,800 sq ft community gaming and event venue - Coordinating venue improvement initiatives, event logistics, vendor relations, and community engagement - Supporting tournament concepts, arcade/pinball integration, and repeat-traffic entertainment strategies - Helping establish operational workflows for events, maintenance, customer experience, and space utilization - Collaborating with stakeholders to transform underutilized commercial space into a multi-purpose community venue
Support the development of Memo, the world’s first consumer household robot, by collecting real-world task demonstrations used to train cutting-edge AI models. Collaborate with the robotics team to shape how Memo learns, remembers, and interacts safely and intuitively in the home.
• Conducted execution for V&V Phase towards FIH (First In Human) FDA submission for product in the field of cardiovascular interventions. • Review and update execution protocol to verify that system integration and functional requirements are properly implemented. •Reported issues for analysis during build stability testing in preparation for V&V cycle. • Execute dry-run for system-level integration and provided feedback for review
• Conducted execution for V&V Phase towards FIH (First In Human) FDA submission for product in the field of cardiovascular interventions. • Execution of test cases to verify software design and functional requirements are properly implemented. • Reported issues for analysis during build stability testing in preparation for V&V cycle. • Performed comprehensive system-level testing and provided detailed analysis within established protocols.
Performing Software QA Engineering responsibilities in preparation for V&V phase towards DFA submission for Neptune Medical. Worked on the fully flexible medical robot is set to disrupt the field of flexible endoscopy by offering capabilities far beyond current technologies. By enabling deep anatomical access with unprecedented precision and control that will set a new benchmark in the field of minimally invasive surgery.