制造工程师

作为定制式正畸产品的制造工程师，负责新项目及量产过程中的生产制造工艺方面的相关工作。

Responsibilities/岗位职责:

61 As the key role of project team to handle manufacture engineering related work such as technical evaluation, transform design input to MFG process.

作为项目团队的关键成员负责制造工程相关的事宜，如设计输出的技术评估及设计输入转化。

61 Develop new process, define layout out &VSM.

负责开发新的工艺流程；设计新产线布局和价值流图。

61 Select equipment based on drawing/Spec requirement as well as design fixtures/tooling/jigs and setup new production line。

根据图纸和标准的要求确定设备的选型以及设计相应的工具治具和工装。

61 Lead the process and quality trouble shooting and coordinate cross function team to meet QDIP target

主导解决产线的工艺问题质量问题并协调横向职能部门达成负责产线的QDIP 指标。

61 Prepare qualification/validation documents (Validation Plan, IQ,OQ, PQ、PFEMA、WI/DHR), complete PV and complete qualification and validation reports.

负责编写新生产线相关的文档（验证计划，IQ/OQPQ，PFMEA，WI/DHR）,执行新产品的过程验证并形成报告。

61 Implement ECR & ECN for product changes and coordinate with related department to make it smoothly.

执行完成相应的工程变更并协调相应职能部门使之在负责的工艺中得到正确实施。

61 Contact with supplier for related project issues, including cooperate with supplier to contact with tooling plant for tool modification and improvement.

协调一些供应商原材料问题，与供应商一起改善原材料质量。

61 Continuously improve the performance (Quality, Delivery, Cost)

量产生产线的关键指标（Q，D，C）的持续改善

61 Maintain part number and BOM, routing in ERP system (SAP).

ERP系统内对主数据，BOM,及工时的维护。

61 Prepare documents for audits from FDA, CFDA and TUV，BSI….

为了FDA，CFDA及TUV，BSI等机构的审核准备相关文件

61 technical training for team member

培训团队成员相关知识支持

61 Participant and ensure the related QMS & GMP regulatory will be well executed in shop floor.

参与并确保相应的质量体系和GMP规范的实施与执行

61 Complete any other duties as assigned by manager

其它上司安排的工作任务

Requirements/岗位要求:

61 Bachelor or equivalent Degree, major in Electrical/Mechanical/Material Science, at least 3 years working experience; experience of medical product will be preferred.

本科或以上学历，电气、机械或材料学专业，至少3年以上的工作经验，有医疗行业背景佳。

61 Prefer to be familiar with the process of 3D printing/CNC/Lase marking /laser cutting/, thermal forming；the more the better.

熟悉3D打印/CNC/激光刻码/激光切割/热成型等工艺的***，越多越好。

61 Master of PSP, DOE Finish bone, 5W2H, PDCA，8D, QC 7 tools ,CAPA such problem solving related tools

能熟练掌握并使用常见问题的分析处理工具包括并不限于PSP,DOE鱼骨图，5W2H, PDCA, 8D，质量7大工具，CAPA等

61 Positive and self-motivated with high pressure and strong problem-solving skill with trouble detecting, analyze and fixing.

积极主动，抗压能力强，善于敏锐的发现潜在问题并具备良好的问题分析与解决的能力。

61 Be familiar with the new process development based on the product TSP

熟悉根据产品技术规范开发导入新的生产工艺的流程

61 Fluent in English will be plus, be able to attend conference call with foreign teams and discus technical problems

英语熟练，可以与国外团队开电话会议并交流技术问题

61 Good knowledge and experience in lean manufacture

有相关精益生产的经验