--Support the creation of manufacturing and development control plan. -Identify potential risks in the end to end development. Processes including material handling, transportation…etc. -Create process Failure Mode and Effect Analysis (FMEA) for General and Project related processes to assess the potential risks for each piece of equipment used in the assembly/testing process and in-between processes e.g. handling between assembly area and warehouse. -Review Design FMEA provided by the design office in order to understand the functionality and the potential risks engendered by the assembly of each component. -Call cross-functional meetings including staff members from Automation, Design office, Project Management, Quality Assurance, Validation, etc. to communicate all open items from the FMEA reports and discuss solutions to mitigate the risks. -Attend Nonconforming Material Report (NCMR) and Complaint meetings relevant to one’s scope and update FMEA report when judged necessary by the project team. -Attend f2f and phone meetings, and project related workshop with overseas colleagues as well as customers

瑞健集團(SHL)成立於1989年，目標以西方管理模式在亞洲打造具有國際水準的生產中心。如今，在全球製藥及生物科技領域，SHL已成為藥物輸送系統的OEM/ODM領導製造商，如自動安全注射器。除此之外，SHL還擴展許多產品線，像是軟性結構類醫療產品、醫療氣墊床、醫療床、腦神經手術器具、工業 設備和醫療用吊昇設備等，目標市場為北美、歐洲及亞洲。 SHL (Scandinavian Health Ltd) is currently the world's largest privately-owned designer, developer and manufacturer of advanced drug delivery systems. The organization was established in 1989 by Swedish entrepreneurs Roger Samuelsson and Martin Jelf with the goal of combining world-class manufacturing in Asia with the strengths of Western Management practices. SHL manufactures devices including pen injectors, auto injectors and inhaler systems. We also manufacture a range of other products including pressure mattress systems, patient lifting slings, medical soft goods, beds, neurosurgical devices, catheters and industrial equipment.