Jinyu Huang

7-year new product development experience in medical device: Expert knowledge in designing and developing new/improved polymeric/biomaterials (silicone hydrogels, hydrophilic polymers, medical implants, etc.), formulations, and surface coatings (plasma and wet chemistry); Extensive knowledge in process design/transfer associated with medical device manufacturing such as scale-up of synthesis and formulation, molding, UV (radical/cationic)/thermal curing, plasma treatment coating, hydrophilic coatings, extraction, sterilization Solid knowledge in using material science knowledge to critically evaluate and develop test methods and procedures for material characterizations such as polymer chemical composition, bulk and surface morphology and microstructure, and physical properties Proficient in experimental design and statistical analysis of data, root cause analysis (FMEA), lean process, and decision making, “Innovation, Quality, Productivity (IQP) Silver Belt” certificated from Novartis Extensive experience in leveraging contract research/manufacturing for new product development/commercialization Extensive knowledge in medical device manufacturing, material/device stability/toxicology, clinical, qualification /validation of instrument and process, GLP/cGMPs, FDA regulations in medical device industry Hands-on experience on project management such as “stage-gate” process in product research/ development/production Excellent communication/management/technical leadership skills: 5 year management experience, leading technical core teams and mentoring research personnel Specialties: Design and develop polymer materials for a variety of applications such as contact and IOL lenses, wound dressing, drug delivery, dental, medical implants, costometic, elastic elastmers, and adhesives; Living/radical/ring opening polymerization; Polyurethane chemistry; Hydrosilylation chemistry; UV(radical/cationic)/thermal curing; Manufacturing process design and transfer