Joe Chen Email & Phone Number

Shanghai, China

Shanghai, China

■ Be responsible for operating testing and evaluation center to lead the definition/ development of testing methods and evaluation/ interpretation of test results in the product development process, ex: prototype performance, design verification, product stability, process validation.■ Investigate and monitor the development of heart valve materials, conduct raw pericardium materials handling and anti-calcification formulations of bovine heart valve materials.■ Lead materials selection, materials verification and biocompatibility evaluation for Transcatheter Mitral/ Tricuspid Valve Repair device, Transcatheter Mitral Valve Replacement device and Trans-jugular Intrahepatic Portosystemic Shunt device.■ Conduct early-stage materials and process investigation, development and assessment, ex: screening potential suppliers, preliminary lab tests of new materials or formulations, establishing materials database, process development (such as pickling, grinding, electro-polishing, plasma treatment, heat treatment, etc.)■ Guide quality team to perform sterility, bioburden, endotoxin, particulate contamination, and chemical properties and establish the acceptance criteria.■ Support manufacturing, quality and regulatory affairs team to conduct root cause analysis and solve the issues from materials, process and biosafety.

Shanghai, China

■ Establish and implement SOP for biocompatibility evaluation and be responsible for relevant technical documentation.■ Be responsible for biocompatibility evaluation for new products in China and line extended products from USA.■ Develop biocompatibility evaluation strategy including materials characterization, biological tests, drug compatibility, extractables/ leachables studies or any studies related to safety of product.■ Cooperate with R&D members to develop new products including leading materials selection and evaluation, solving the issues of materials and biocompatibility.■ Support regulatory affairs, quality team and manufacturing to clarify the issues of the safety of materials and products.

Dongguan, Guangdong

■ Perform literature, patent research and marketed product analysis to identify the potential application of in-house made TPUs.■ Cooperate with customers to identify the opportunities for developing new products and provide relevant technical assistance.■ Plan and perform materials and additives selection, formulation design, lab syntheses, performance testing and process development (ex: injection molding, extrusion, hot melt, etc.).■ Be responsible for lab testing, pilot run and mass production and establish technical specifications for raw materials and products.

Hualien, Taiwan

Kaohsiung, Taiwan

■ Perform raw materials selection (mainly ceramics and polymers), formulation design, process development, literature research and patent preparation.■ Evaluate biocompatibility and conduct animal studies, physical and chemical properties of bone substitute products (class II/ III medical devices) and antibacterial materials.■ Be responsible for lab testing, sample build, scale-up work, establishing technique specifications of bone substitute products.■ Assist to establish ISO quality system (ISO 9001/ ISO 13485) and GMP and lead Ezechbone ® to get Taiwan FDA registration approval.■ Cooperate with delivery system team to develop bone cement delivery devices.