Job Description
・Drive new product development activities in accordance with approved timelines and project plans. ・Ensure implementation and compliance with ISO 9001, ISO 14001, ISO 13485, and applicable medical device regulations. ・Create and maintain Bills of Material (BOM) for development products. ・Develop and manage product development schedules in coordination with cross-functional departments (R&D, Quality, Manufacturing, Purchasing, etc.). ・Analyze product or process abnormalities, identify root causes, and implement corrective actions based on data. ・Monitor development progress and ensure products run according to plan, schedule, and performance targets. ・Prepare and calculate development product costs to support decision-making and management review. ・Other duties as assigned.
Job Requirement
・Bachelor's Degree from Engineering / Industrial Engineer / Biomedical Engineer. ・3 years of experience as R&D Product Supervisor ~ Assistant Manager handling Medical Device product. ・Business English proficiency