Process Engineer-Machining
Summary
Process Engineer in Guangzhou sets up high-precision diamond turning, milling, and tumbling manufacturing lines, validates equipment, and improves production processes using lean and Six Sigma tools.
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 diamond turning lathing and milling equipment and tumbling equipments, prepare the drawing/URS/IQ/OQ/PQ protocol and finish validation of equipment
与采购团队合作，主导高精密金刚石车铣削设备及抛光设备采购，并独立编写图纸/URS/IQ/OQ/PQ方案和完成设备确认。
3. Dedicated to the introduction and improve of diamond turning lathing and milling and tumbling manufacturing process, responsible for the compilation of relevant production documents, collecting and analisys process data, lead process improvement
致力于金刚石车铣削及抛光制程工艺的导入，负责相关生产文档的编译和数据收集，负责工艺改善。
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。
4. Manufacturing process performances improvement through CIP tools such as lean, 6 sigma or other approach. Support production team to secure production performance.
以CIP工具（如精益、6 Sigma等），改进制造工艺及技术以不断提升制造水平。
1. Responsible for diamond turning lathing and milling process and tumbling process set-up for new production 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
负责在新工厂中建立高精密金刚石车铣削制造工艺及抛光制造工艺：
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. Industrialization of new products developed by R&D department
a. To implement production process of new products in the plant
b. To improve production process for mass production of new products based on process concepts developed by R&D
c. To implement and validate necessary tools, production equipment, measurement devices or software.
d. To define in process inspection criteria according to validation result (PQ).
e. 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...
f. To adapt workstation to insure efficient and safe production (for the product and for production staff).
g. To provide input for master data update (ERP)
h. To provide training to production staff.
负责与研发部门对接，推进新产品工艺设定，实现新产品工业化生产
a. 新产品生产工艺的实施
b. 根据研发部开发的工艺理念，改善新产品的量产工艺
c. 实施和确认必要的工具、生产设备、测量设备和软件
d. 根据PQ的验证结果定义过程检验标准
e. 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
f. 调整工作台以确保生产效率和生产人员及产品的安全
g. 为ERP系统基础数据更新提供输入信息
h. 为生产人员进行培训
3. Development of new manufacturing technology or solution in order to increase production capacity and decrease cost of production with high quality standard based on technology roadmap 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
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