岗位概述 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与项目组及国外团队合作，支持新生产线建立，按照精益原则建设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与采购团队合作，主导相关工艺设备采购（例：黏合、热封、测量、工作台、灌装设备、组装等），并独立编写图纸/URS/IQ/OQ/PQ方案和完成设备确认。

3. Responsible for the compilation of relevant production documents, collecting and analisys process data, support process improvement;负责相关生产文档的编译和数据收集，支持工艺改善。

4. Lead machines/process validations, finish IQ/OQ/PQ protocol and report.负责相关设备工艺验证活动，独立完成IQ/OQ/PQ 方案和报告。

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.; 负责和推动新产品、新工艺、工艺改善变更控制， 协调跨部门以按照流程完成变更控制， 包括启动，申请资料准备、风险分析、验证计划等；

岗位职责 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

主导在新工厂中建立高精密光学产品的制造工艺：

a. 推动并执行制造工艺的实施

b. 推动并执行新工厂的工程任务

c. 制定标准并采购所需的生产设备和消耗品

d. 对制造流程和产品进行确认

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...

负责推进新产品工艺设定，实现新产品工业化生产

a. 根据研发部开发的工艺理念，改善新产品的量产工艺

b. 实施和确认必要的工具、生产设备、测量设备和软件

c. 为生产团队更新或创建必要的生产文件，确保稳定、安全和高效的生产。SOPs 包括工艺参数、检验指导书，点检表等

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

基于与总部工艺接轨的技术路线图，开发新的制造技术或解决方案，以保证高质量标准的同时，提高生产能力，降低生产成本

a. 识别生产能力（产能分析，交货期分析）和生产成本（劳动效率，材料收益率）方面的改善潜力

b. 基于业务案例分析，以结构化的方法开发新技术

c. 使生产线自动化，以提高生产过程的稳定性，降低镜片单片成本，优化物流

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

通过CIP工具（如精益工具，6σ或其他方法）改善现有制造技术，并提供生产支持

a. 改进现有生产设备的OEE

b. 优化现有生产设备的生产能力

c. 主导PDCA循环过程持续改进制造能力

5. Ensures the production procedure, activities and technologies to comply with GMP, FDA, ISO13485 and other regulations and standards确保生产流程、活动和技术符合GMP, FDA及ISO13485等法规和标准

6. Contributes to continuous process optimization and its standardization within global CZ Meditec Group致力于全球卡尔蔡司医疗集团的工艺优化和标准化持续改善

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，机械/材料/化工/电子等工程学科

Bechalor or above Major in mechanical / material / chemical / electrical / industrialengineering

工作经验/经历 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年以上工艺工程师工作经验，跨工公司相关工作经验为佳。学业优秀或表现突出者可适当放宽工作经验要求；

2. Experinece in manufacturing of medical device or any product in high quality/high technology standard environment (e.g. automotive electronics, semiconductor) ispreferred具有医疗器械制造行业或其他高质量/高技术标准（如汽车电子，半导体）制造业相关工作经验优先

3. Experience of intercontinental production line transfer and process equipment installation/validation/trouble shooting is preferred.国际间生产线转移和工艺设备安装/验证/故障排除经验者优先

专业知识/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.普通话及英语听说读写流利，具备跨国公司及海外工作经验为优

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.熟悉医疗及食品行业洁净间卫生要求，具备常规消毒及灭菌工艺知识者优先；熟悉精密器件抛光、镀膜、清洗及外观检查工艺知识者优先。

3. Comprehensive experience to use tools and methods of 6 signma management and lean manufacturing.具备综合运用六西格玛及精益生产相关理论和工具方法的实践经验

4. Experience of data analysis (JMP, SPC, Minitab) and DOE principles.具备数据分析(如JMP, SPC, Minitab)和DOE实验设计的应用经验

行为能力 Behavioral Traits

1. The ability to play key role in teamwork with proven communication skills in dealing with all levels of staff is essential.具务在团队合作中发挥关键作用的能力及与各级员工打交道的沟通技巧。

2. Fast-learning ability, be able to master production related knowledge具备快速学习能力，能迅速掌握生产相关知识

3. Excellent problem identification, analysis skills and improved action execution ability with result orientation具备优秀的问题识别、分析能力，及以结果为导向的改善行动执行能力

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.身体健康，热爱运动，出差时能够良好适应各地区时差。

2. Be able to invest sufficient time and energy to focus on the progress of the project.能够以项目进度为导向，充分投入工作时间和精力。