ZEISS Group

Process Engineering supervisor

Guangzhou Full time

1. Leading and managing process engineering team (normally 5-12 members), to ensure manufacturing process comply with medical device standards and regulatory requirements; Take responsibility on target management, performance review and communication, coaching and development with each team member;

带领和管理工艺工程团队(通常5-12人), 来确保制造工艺符合医疗器械行业标准和法规要求; 负责与团队成员的目标设定、绩效回顾及沟通、辅导和发展等;

2. Take responsibility of develop key procedure/instructions/templates to be professional and standard, to identify PDCA cycle to keep improving whole team understanding on documents and compliance(regualations, standards, quality system);

 负责主要流程、指引、模板的专业化标准化, 制定PDCA流程以持续改善团队对文件的理解及合规合体系的风险考量;

3. leading team to focus on related process daily issues and problem solving, investigating and root cause definition, correct and prevent issues by short-term and long-term solutions;

带领团队关于相关工艺的日常问题解决,  调查和识别根本原因, 采取短期长期措施修复和预防相关问题;

4. leading team to focus on related manufacturing process performances improvement through CIP tools such as lean, 6 sigma or other approach. Support production team to secure production performance, improve efficiency and reduce cost;

带领团队以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.  支持生产团队确保制造水平, 提升效率, 降低成本;

5. leading team to focus on related process lifecycle management, to test and validate new materials, new process, new technology etc.

 带领团队关注相关工艺的生命周期管理, 测试和验证相关新材料、新工艺、新技术等;

6. leading team to support projects, including new products introduction, new production line build up, Automation & digitalization; to support audit from Zeiss group, regulatory agent, Government, etc.

带领团队支持相关项目包括新产品导入, 新生产线建立, 自动化和数字化等; 支持来自蔡司集团、监管机构、政府的审核等;

1. Se-up new IOL/consumable production 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 new plant

c. To build the Chinese engineering team

d. To specify required production equipment and consumables

e. To qualify and validate the process and products

负责建立新医疗耗材生产线:

a.主导并按时实施生产工艺;

b. 主导并完成工厂的工艺任务;

c.定义产线设备和生产耗品的规范和标准;

d.完成工艺验证和确认;

2. Industrialization of new products developed by R&D department (tasks to be handle by him/herself or delegated to the team depending on project size and resource availability):

a.To implement 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.

将设计开发的新产品进行工业化:

a.在工厂实施新产品工业化;

b.根据研发开发的工艺概念,改进新产品的量产生产工艺

c.实施和验证必要的工具、生产设备、测量装置或软件。

d.根据验证结果(PQ)确定过程中检验标准。

e. 确保一致、安全和高效的生产,为生产人员更新或创建必要的文件,如SOP, 包括工艺参数、检验说明、规格表等

f.调整工作站以确保高效和安全的生产(为产品和生产人员)。

g.为主数据更新(ERP)提供输入

h.为生产人员提供培训。

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

根据与全球工程部一致的技术路线,开发新的制造技术或解决方案,以便以高质量标准提高生产能力并降低生产成本:

a. 确定生产能力(产能分析、提前期分析)和生产成本(劳动效率、材料生产率、其他成本)方面的潜在改进部分并实施改进。

b. 根据商业案例分析,以结构化方法(项目管理形式)开发新技术。

c. 使生产线自动化,以提高工艺稳定性,降低每个镜片的成本,并优化材料流

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. Coordinate Manufacturing technology & Process engineering actions with other IOL manufacturing plants (e.g. La Rochelle, Berlin etc.):

a.To coordinate activities between both sites Process engineering teams, to define priorities and align project plans.

b.To develop individual expertise of team members in order to cover the whole range of technology for IOL mfg

c.To improve team expertise level on industrialization project management.

与其他IOL制造工厂(如拉罗谢尔、柏林等)协调制造技术和工艺工程行动:

a.协调两个现场过程工程团队之间的活动,确定优先级并调整项目计划;

b.发展团队成员的个人专业知识,以涵盖IOL制造的整个技术范围;

c.提高团队在工业化项目管理方面的专业水平。

6. 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;

7. 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

8. Establishes policies, goals, budgets, plans, and procedures related to areas of responsibility.

制定与责任领域相关的政策、目标、预算、计划和程序

9. Contributes and collaborates to international cross-site projects, defined within CZM.

为集团内定义的国际跨工厂项目做出贡献和合作。

10. Other tasks assigned by direct leader

其他由直接上司安排的工作

Your ZEISS Recruiting Team