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;
任职资格 Qualification
1.Bachelor or aboveMajor in Mechanics, Applied mechanics, Physics, Material related. 本科或以上,机械、应用机械、物理、材料相关专业毕业;
2.Minimum 5 years supervisory experience required, or young talent. 最少5年作为团队主管的相关经验, 业绩优秀或表现突出的人才可适当放宽;
3. Minimum 5 years’ experience in process engineering required最少5年工艺或制造工程类相关经验;
4. Experience in manufacturing of medical device or Pharmacy or any product in high quality/high technology standard environment (e.g. automotive electronics, semiconductor) is preferred. 具有医疗器械制造行业或制药或其他高质量/高技术标准(如汽车电子,半导体)制造业相关工作经验为优;
5. 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/故障排除经验者为优;
6. Experience in lean manufacturing, or six sigma. 具备精益制造或6西格玛经验;
7. 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。