Cheng-Pao Chen

Experience

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  Central Medical Technologies, Inc.

  Jan 2014 - Sept 2016

  R&D Engineer

  Research and development of new product, material.-Search, collect and sort regular and reference.-Execution and design of experiment.-Make a conclusion of study result, writing reports.-Planning verification of product and material.-Planning and execution project with external organization.Project management and coordination among teams.-Project preparation, execution and follow-up.-Proposed and evaluated the feasibility of new projects in R&D dept. and other department.Manufacture process and quality assurance assistance.-Analysis, improve and validation of process.-Establish product technical document (TCF).-Proposed and revised the product inspection procedures, inspection instructions and criteria.- Proposed and revised instrument operating instructions.Quality systems and regulatory experience.-TFDA, CFDA, FDA 510 (k), CE Mark.-Medical device GMP quality system.-ISO I3485 Medical devices quality management systems.-ISO 14971 Risk Management to Medical Devices-ISO 11135, ISO 11137, ISO 11607 Show less

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  Shanghai Harmony Biotech Co.,Ltd

  Mar 2017 - Sept 2021

  Research And Development Manager
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  Shanghai Lange Medtech Co., Ltd.

  Oct 2021 - now

  Deputy Director of Research Development