Xunchang "Shaun" Chen

Well-versed technical leader with a global vision in defining, developing, and commercializing innovative products (from concept to launch). Passionate about making advanced technologies more accessible. ● Proven track records of leading stage-gate product development for complex and connected optical instruments● Strong technical background in optics, ultrasound, surgical microscope, multi-modality imaging, human vision, and instrument design and robotic systems integration● Extensive work experience in global matrix environment in both MNCs and startups. ● Spearheaded digital transformation including connectivity, AI-enabled medical devices, and future cloud-based telemedicine platform● Adept at identifying unmet customer needs and market opportunities● Experienced with Design for Manufacturability, Serviceability, Quality/Reliability, etc. ● Hands-on experience of design transfer and NPI using contract manufacturers in Asia● Understanding of medical device regulations including 21CFR 820/ISO13485, ISO14971, IEC62304, laser safety IEC60825 etc. ● Extensive knowledge of design controls for medical devices. Experience in risk assessment and risk management● Familiar with medical device testing procedures including IEC 60601-1/60601-1-2(EMC) and other environmental, transportation & packaging, biocompatibility testing etc.● Acquainted with clinical study and regulatory submission processes for CE marking, FDA 510(k), and CFDA registration● Experienced with analyzing IP, developing IP strategy, and managing IP portfolio