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Recommend, design, select machinery, tools, jigs, and fixtures required to machining the products. 建議、設(shè)計(jì)、選擇加工產(chǎn)品所需的機(jī)械設(shè)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(tǒng)中維護(hù)條款主文件、產(chǎn)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(xùn); Responsible for continuous improvement initiatives, such as projects to improve quality, cost, delivery and efficiency. 負(fù)責(zé)持續(xù)改進(jìn)舉措，例如改進(jìn)質(zhì)量、成本、交付和效率的項(xiàng)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(jìn)流程并減少非附加值的浪費(fèi)和活動。 （包括過程FMEA，Gauge R＆R，預(yù) 測指標(biāo)和統(tǒng)計(jì)技術(shù)的使用）。 Participate to identify capital spend and budget requirements. 參與確定資本支出和預(yù)算需求。 Participate or lead layout design / implementation for facility and equipment. 參與或領(lǐng)導(dǎo)設(shè)施和設(shè)備的布局設(shè)計(jì)/實(shí)施 Support R&D on new products development and quality system implementation. 支持新產(chǎn)品開發(fā)和質(zhì)量體系實(shí)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(zhì)量理念 Understand, compile and control non-conformance data and product tractability. 理解、編制和控制非符合項(xiàng)數(shù)據(jù)和產(chǎn)品易追溯性 Responsible for creating and maintaining manufacturing documentation for equipment and processes. 負(fù)責(zé)創(chuàng)建和維護(hù)設(shè)備和流程的制造文件 Responsible for compiling the validation/verification protocols and completing studies by creating finished reports. 負(fù)責(zé)編制驗(yàn)證/確認(rèn)協(xié)議，并創(chuàng)建完成的報(bào)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，F(xiàn)PI等... Understand computer software validation requirements. 理解計(jì)算機(jī)軟件驗(yàn)證要求