7+ years in regulated medical device environments — software V&V, quality engineering, and cross-functional program management across firmware, mobile, and cloud platforms. FDA 510(k) submissions, ISO 13485, IEC 62304. Open to Senior V&V, Quality Engineer, R&D PM, and TPM roles.
Senior Verification & Validation Engineer and Program Manager with 7+ years of experience in regulated medical device environments. Deep background executing end-to-end software V&V across firmware, mobile (iOS/Android), and cloud systems — from test protocol authoring through FDA 510(k) submission and design history documentation under IEC 62304 and ISO 13485.
Equally experienced as a Technical Program Manager — simultaneously driving multiple concurrent R&D programs across engineering, quality, and regulatory teams, coordinating 200+ device validation studies, and managing cross-functional programs from concept through regulatory submission readiness. Brings a rare combination of hands-on V&V technical depth and program management execution.
7+ years across software V&V, quality engineering, and program management in regulated medical device environments.
Technical depth and regulatory expertise across software V&V, quality engineering, and connected medical device platforms.
Key programs across connected medical devices, mobile applications, and data infrastructure.
Formal education in informatics and Chinese studies, with professional certification in project tooling.
Side projects that demonstrate hands-on technical depth beyond my professional roles.
Recent LinkedIn recommendations from colleagues at BioIntelliSense.
"I have had the privilege of working with Chensi for over eleven years across two of my companies — first at Striiv, and then at BioIntelliSense. Chensi is one of the most dedicated, thorough, and results-driven professionals I have worked with. At BioIntelliSense, Chensi became the go-to person for complex and high-stakes testing efforts. He executed comprehensive V&V test plans that covered all topologies of data connectivity, from wearable-to-phone Bluetooth pairing, to gateway-to-cloud data pipelines, ensuring end-to-end reliability of our patient monitoring systems. He coordinated across engineering, product, QA, data science, and regulatory teams with ease — including our BioHub Wi-Fi gateway from concept through deployment — with the kind of ownership and accountability that every founder hopes to find in their team."
"Chensi is a conscientious project manager who delivers reliably in complex, fast-moving environments. He led data collection initiatives supporting BioIntelliSense's first FDA 510(k) submission and maintained operational discipline under tight timelines. He also managed the mobile app team, coordinating cross-functional work to support on-time delivery of key releases. Chensi works well amid ambiguity and changing scope by quickly clarifying priorities, surfacing risks early, and turning open questions into practical, actionable plans that keep teams aligned and moving. His hands-on leadership and follow-through were key contributors to the success of the projects he led and the teams' ability to deliver outcomes under pressure."
"Chensi is a detail-oriented and hard working V&V engineer with strong ownership in system testing and firmware validation. He led firmware compatibility testing for our medical devices and gateways, creating structured test protocols and applying a quality-driven CAPA approach to validation and issue resolution. He improved team efficiency through recurring test frameworks and clear documentation, and brought direct hands-on expertise in Android-based systems, debugging and log analysis. Beyond his technical contributions, Chensi is incredibly fun to work with. He is collaborative, positive, and always willing to support the team, even beyond his initial responsibilities. It is his thoughtfulness and genuine kindness that make him someone you can consistently rely on as a team player."
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Open to Senior V&V Engineer, Quality Engineer, and Quality Program Manager roles in medical devices and regulated software. Reach out anytime.