• Around 7 years IT and about 5 years Medical device industry work experience。Thoroughly familiar with product and project management in paper and practice. • Acquired the certificate of industry engineering from Chinese Institute of Industrial Engineers.• Expert in Project Management Body of Knowledge (PMI,2008) and New Product Development Professional (PDMA). Good at Market research, playing market and product strategy. In the early stage of business, integrating patent, legal, marketing and sales strategies, and then conducting product development and management, sales / pricing / margin control, packing and marketing design, and final integrating enterprise resources into Implementation.• Medical Device Design and Development:Understanding how to merge ID 、human factors、 modeling and mechanical factors to realize portable and wearable devices. Is able to work with R&D team to design UI (User Interface) and OS (Operation Sequence) .• Medical clinical and regulatory:Familiar with major medical safety standards (ISO 13485 / FDA 21 CFR 820 QSR / FDA 510(k) / 93/42/EEC MDD). Having experience in apply 510(k)、CE、 TDFA、 CFDA . Being able to give instruction for R&D / Engineering / Quality / Production Department how to write documents for medical regulatory and highlighting marketing points of clinical / patent / accuracy..etx to for sales approach business. • Smart medical and healthcare:Familiar with the medical application of IOT / Big Data / AI in smart home / hospital industry. Tracking main IT companies (Hon Hai and Foxconn / Asus / Acer / Advantech / Wistron / Compal ) and hospitals (Chang Guang / Cathay ) and understand how the two groups allocate smart hospital / ward / nursing / home care market.