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.
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。
【Job Overview】【職務概述】
This position is a senior technical role in the Metrology Method Development group within our Global Process Development team in Taiwan
【Responsibilities】【職務內容】
- Develop new measurement methods for both engineering studies and mass production quality control from Design for Manufacturing (DFM) to implementation
- Work cross-functionally, closely collaborate with engineers, QA/RA specialists, product management, and external contributors for project execution
- Communicate detailed progress updates within cross-functional meetings
- Lead investigation and improvement for the performance of existing solutions experimentally and theoretically
- Structure and be responsible for corresponding work packages and, if necessary, sub-projects
- Document results and present them internally as well as to customers and international development partners as needed
- Laying the groundwork towards a digital twin
- Other duties may be assigned
- 從工程開發到量產測量方法開發 ,考量範圍包含DFM到實際執行
- 藉由跨部門合作,與工程師、品質及法規部門、產品管理單位...等密切合作,以確保專案時程順利推進
- 在跨部門溝通會議中詳細並有效地進行溝通
- 通過實驗和理論研究,領導調查和改進。
- 將專案及接續有關的子專案結構化,並記錄結果,根據需求給予內部相關單位及外部客戶。
【Qualification】【職務規範】
- An above-average university degree in physics, mathematics or engineering
- Minimum 3 years of relevant industry experience in engineering
- Experience in the development of measurement and adjustment methods highly preferred
- Experience in CMM and/or CT scanning highly preferred
- Experience and knowledge in Metrology (e.g. MSA) and statistic with Minitab preferred
- Previous exposure to a highly regulated industry (e.g. medical, pharmaceutical) and knowledge of relevant standards (e.g. ISO13485, cGMP) is a plus
- Analytical thinking and a high level of comprehension as well as problem solving skills
- Equal ability to work effectively as an individual on one's own initiative and as part of a team in a multi-cultural and multi-disciplinarily environment.
- Strong report writing and communication skills (written & verbal) in English and Mandarin
- 具備物理、數學或工程學相關之學士學位(或以上)
- 至少3年相關工程領域之經驗
- 有測量和調整方法開發經驗者優先考慮
- 具有CMM和/或CT掃描經驗者優先考慮
- 具有量測技術(例如MSA)和統計學知識(Minitab)優先考慮
- 具醫療、製藥相關標準知識(例如ISO13485、cGMP)者為佳
- 具有分析思維、高度理解力以及解決問題能力
- 具有跨文化和跨領域環境中獨立工作, 主動積極, 團隊合作的能力
- 具有撰寫中英文報告及良好溝通能力
