Requirments: ? Partner with R&D team to complete transferring and landing new products and new process as project schedule and related Gate deliverable documents. ? Monitor the in-line product quality performance and continuously optimize the process, specifically use optimization tools to improve productivity, scrap and production efficiency. ? Lead the root cause analysis about top defects. ? Be responsible for OOB(DOA) and complain following, root cause analysis, improvement, and feedback. ? Support QMS regularly auditing. ? Drive Kaizen event to save the space and optimize the process or workflow. ? Cooperate with R&D team for new sourcing material or component verification. ? Work with MTL team to arrange production plan to meet demand. ? Support Service / marketing team about the demo units demand. ? Production line setup with new device, equipment, tools with V&V report as need. ? Initial and revise the WI & SOP as need. ? Train and verify new operators. ? Perform other duties as required. Responsibilities: ? Minimum 5 years with bachelor or over 10 years with colleges, Mechanical or electrical/ electronic major background or related. ? Have Medical Device manufacturing experience, preferably a global company and expertise of project handling is preferred. ? Be familiar in medical manufacturing process and validation procedure and mindset. ? Have rich experience in assembly, system integration, testing. ? Strong process development and problem-solving capability. ? Multi-task handler and great team worker. ? With expertise of Clean Room daily management experience.