Recommend, design, select machinery, tools, jigs, and fixtures required to machining the products. 建議、設計、選擇加工產品所需的機械設備、刀具、工裝與夾具。 Work with other Manufacturing Engineers to maintain the item master, product routings and bills of material in the MRP system. 與其他制造工程師合作，在MRP系統中維護條款主文件、產品工藝路徑和物料清單 Deliver necessary training for workshop employees; 為車間員工提供必要的培訓; Responsible for continuous improvement initiatives, such as projects to improve quality, cost, delivery and efficiency. 負責持續改進舉措，例如改進質量、成本、交付和效率的項目 PE principles to improve processes and reduce non-value-added waste and activities. (Including process FMEA, Gauge R&R, Predictive Indicator and use of statistical techniques). 使用PE原則來改進流程并減少非附加值的浪費和活動。 （包括過程FMEA，Gauge R＆R，預 測指標和統計技術的使用）。 Participate to identify capital spend and budget requirements. 參與確定資本支出和預算需求。 Participate or lead layout design / implementation for facility and equipment. 參與或領導設施和設備的布局設計/實施 Support R&D on new products development and quality system implementation. 支持新產品開發和質量體系實施 Understand the Quality philosophy based on FDA QSRs, ISO 9000 and SFDA requirements. 理解基于FDA QSR，ISO 9000和SFDA要求的質量理念 Understand, compile and control non-conformance data and product tractability. 理解、編制和控制非符合項數據和產品易追溯性 Responsible for creating and maintaining manufacturing documentation for equipment and processes. 負責創建和維護設備和流程的制造文件 Responsible for compiling the validation/verification protocols and completing studies by creating finished reports. 負責編制驗證/確認協議，并創建完成的報告完成研究。 Understand special processes requirements are plus, such as Sterilization, Cleaning, Packaging, FPI etc. 理解特殊工藝要求是加成，如滅菌，清潔，包裝，FPI等... Understand computer software validation requirements. 理解計算機軟件驗證要求