This course focuses on fundamental principles of quality based medical device manufacturing process including documentation control, safety training, lean manufacturing concept, clean room basics, measurement fundamentals, data management, and analysis related to medical device manufacturing. Mastery of these skills is key to successful careers in the medical device and bioscience industry. Students will also learn the techniques to use measuring equipment commonly used in the medical device industry, including caliper and micrometer. These core skills will be taught using a hands-on approach in conjunction with class discussions. In addition, student will apply their computer skills, particularly with Microsoft Word and Excel to develop basic data management and analysis skills. This course will focus on: o Introduction of the basic knowledge of medical device manufacturing process o Introduction to quality-based product development & lean manufacturing principles o Introduction to GMP, GDP, workplace safety, clean room basics, product assembly basics o Introduction of equipment tolerance and selection principle o Instruction of proper application of basic measurement tools, and Gage R&R o Instruction of proper data collection and documentation o Instruction of proper applications of basic math & statistics (sum, average, SD & CV) in data analysis and problem solving