崗位概述 Position Summary
1. Support new production line set up, co-work with project team and overseas team, build efficient and low-cost production process and layout according to lean principle與項目組及國外團隊合作，支持新生產線建立，按照精益原則建設高效率低成本制程及布局。
2. Coorperate with procurement team to lead the purchasing of process equipment(e.g. blocking/sealing/measurement/workstation/filling/assembly machine etc.), preparethe drawing/URS/IQ/OQ/PQ protocol and finish validation of equipment與采購團隊合作，主導相關工藝設備采購（例：黏合、熱封、測量、工作臺、灌裝設備、組裝等），并獨立編寫圖紙/URS/IQ/OQ/PQ方案和完成設備確認。
3. Responsible for the compilation of relevant production documents, collecting and analisys process data, support process improvement;負責相關生產文檔的編譯和數據收集，支持工藝改善。
4. Lead machines/process validations, finish IQ/OQ/PQ protocol and report.負責相關設備工藝驗證活動，獨立完成IQ/OQ/PQ 方案和報告。
5. Lead and drive new product, new process, process improvement change control, coordinate cross-function to finish change control follow procedure, including kick-off,application materials preparation, Risk analysis, validation plan etc.; 負責和推動新產品、新工藝、工藝改善變更控制， 協調跨部門以按照流程完成變更控制， 包括啟動，申請資料準備、風險分析、驗證計劃等；
崗位職責 Responsibility
1. Lead setup relevant process for high precision product manufacturing line in China:
a. To drive and execute timelines and implementation of the production process
b. To drive and execute actions within engineering tasks for the process
c. To specify and purchase required production equipment and consumables
d. To qualify and validate the process and products
主導在新工廠中建立高精密光學產品的制造工藝：
a. 推動并執行制造工藝的實施
b. 推動并執行新工廠的工程任務
c. 制定標準并采購所需的生產設備和消耗品
d. 對制造流程和產品進行確認
2. Lead on industrialization of new products developed by R&D department
a. To improve production process for mass production of new products based on process concepts developed by R&D
b. To implement and validate necessary tools, production equipment, measurement devices or software.
c. To update or create necessary documentation for Production staff in order to insure consistent, safe and efficient production: SOPs including process parameters, inspection instruction,specifications tables...
負責推進新產品工藝設定，實現新產品工業化生產
a. 根據研發部開發的工藝理念，改善新產品的量產工藝
b. 實施和確認必要的工具、生產設備、測量設備和軟件
c. 為生產團隊更新或創建必要的生產文件，確保穩定、安全和高效的生產。SOPs 包括工藝參數、檢驗指導書，點檢表等
Development of new manufacturing technology or solution in order to increase production capacity and decrease cost of production with high quality standard based on technologyroadmap aligned with Global Engineering:
a. To identify improvement potentials regarding production capacity (capacity analysis, lead time analysis) and cost of production (labour efficiency, material yield rate, other costs).
b. To develop new technology in a structured approach (project pipe line) based on business case analysis.
c. To automate the manufacturing line to improve process stability, to reduce cost per lens and to optimize material flow
基于與總部工藝接軌的技術路線圖，開發新的制造技術或解決方案，以保證高質量標準的同時，提高生產能力，降低生產成本
a. 識別生產能力（產能分析，交貨期分析）和生產成本（勞動效率，材料收益率）方面的改善潛力
b. 基于業務案例分析，以結構化的方法開發新技術
c. 使生產線自動化，以提高生產過程的穩定性，降低鏡片單片成本，優化物流
4. Performances improvement of existing manufacturing technology through CIP tools such as lean, 6 sigma or other approach and production support to secure production performance:
a. To improve OEE of existing manufacturing equipment.
b. To optimize capacity of existing manufacturing equipment.
c. To lead PDCA loop of production capacity continuous improvement
通過CIP工具（如精益工具，6σ或其他方法）改善現有制造技術，并提供生產支持
a. 改進現有生產設備的OEE
b. 優化現有生產設備的生產能力
c. 主導PDCA循環過程持續改進制造能力
5. Ensures the production procedure, activities and technologies to comply with GMP, FDA, ISO13485 and other regulations and standards確保生產流程、活動和技術符合GMP, FDA及ISO13485等法規和標準
6. Contributes to continuous process optimization and its standardization within global CZ Meditec Group致力于全球卡爾蔡司醫療集團的工藝優化和標準化持續改善
7. Other tasks assigned by direct leader其他由直接上司安排的工作
教育背景 Education Background
本科及以上，機械/材料/化工/電子等工程學科
Bechalor or above Major in mechanical / material / chemical / electrical / industrialengineering
工作經驗/經歷 Work Experience
1. Minimum 3 years’ process engineering experience in high precision manufacturing industry, preferably in multinational company.If performance or study excellent,relaxation of requirement on work experience is possible.3年以上工藝工程師工作經驗，跨工公司相關工作經驗為佳。學業優秀或表現突出者可適當放寬工作經驗要求；
2. Experinece in manufacturing of medical device or any product in high quality/high technology standard environment (e.g. automotive electronics, semiconductor) ispreferred具有醫療器械制造行業或其他高質量/高技術標準（如汽車電子，半導體）制造業相關工作經驗優先
3. Experience of intercontinental production line transfer and process equipment installation/validation/trouble shooting is preferred.國際間生產線轉移和工藝設備安裝/驗證/故障排除經驗者優先
專業知識/技能 Knowledge And Skill
1. Ability to communicate in English and Mandarin, in both written and verbal form. Experience working in a multinational company and oversea working experience is a plus.普通話及英語聽說讀寫流利，具備跨國公司及海外工作經驗為優
2. Understanding of higiene requirement in medical and food industry with knowledg in disinfection and sterilization process will be prefered; Understanding of polishing,coating, cleaning and visual inspection process of high precision product manufacturing will be prefered.熟悉醫療及食品行業潔凈間衛生要求，具備常規消毒及滅菌工藝知識者優先；熟悉精密器件拋光、鍍膜、清洗及外觀檢查工藝知識者優先。
3. Comprehensive experience to use tools and methods of 6 signma management and lean manufacturing.具備綜合運用六西格瑪及精益生產相關理論和工具方法的實踐經驗
4. Experience of data analysis (JMP, SPC, Minitab) and DOE principles.具備數據分析(如JMP, SPC, Minitab)和DOE實驗設計的應用經驗
行為能力 Behavioral Traits
1. The ability to play key role in teamwork with proven communication skills in dealing with all levels of staff is essential.具務在團隊合作中發揮關鍵作用的能力及與各級員工打交道的溝通技巧。
2. Fast-learning ability, be able to master production related knowledge具備快速學習能力，能迅速掌握生產相關知識
3. Excellent problem identification, analysis skills and improved action execution ability with result orientation具備優秀的問題識別、分析能力，及以結果為導向的改善行動執行能力
特殊要求 Special Requirement
1. Good health and mental state with regular participation of sports, be able to work in different timezone during business trip.身體健康，熱愛運動，出差時能夠良好適應各地區時差。
2. Be able to invest sufficient time and energy to focus on the progress of the project.能夠以項目進度為導向，充分投入工作時間和精力。