高级工艺工程师（介入类医疗器械）

岗位职责：

• Find and solve the problems of the process, technology and raw material on the production line.

  发现并解决生产线出现的过程问题， 工艺问题， 原材料问题等。

• Lead and participate in process design, process verification/validation for neurovascular intervention products; To establish the related plans, protocol, report and operation instructions.

  主导并参与脑血管介入产品的工艺设计、工艺验证、过程确认，及编写相关方案、报告、作业指导书。

• Experienced in implementing IQ/OQ/PQ/PPQ.

  有实施IQ/OQ/PQ/PPQ的经验。

• Prepare operation instructions, drawings, and product’s quality requirement.

  编写作业指导书，材料和成品图纸，产品质量要求。

• Troubleshoot for equipment and tooling, as well as some simple equipment maintenance.

  设备和工装的故障排除， 简单的设备维修。

• Experienced in risk management and risk analysis during process design and process validation.

  具有设计和过程风险管理， 风险分析的经验。

• Lead process improvement, increase product’s yield rate , improve production efficiency, and reduce waste.

  主导工艺流程优化的项目，提升产品合格率与生产效率，降低生产成本。

• Lead nonconformity handling, operators training and manufacturing process improvement.

  主导生产异常处理、培训操作人员、工艺流程改善。

• Design and maintain the tooling and equipment.

  工装夹具和设备的设计及维护。

• Cooperate with R&D, production and quality departments on product design and function test.

  协同研发、生产、品质部门进行产品的研发及性能检测。

• Experienced in mass production of medical devices.

  具有产量生产医疗器械的经验。

• Experienced in data analysis and statistics.

  分析数据， 有实用性的统计学知识。

  
  

岗位要求：

• BS Degree in Engineering, MS Degree and experienced workers in medical device field is preferred.

  材料、机械、机电等相关专业背景，本科及以上学历；有医疗器械行业工艺从业经验者优先。

• Experience in problems solving and data analyzing.

  具有问题分析能力， 能够有效的使用数据分析做出决策。

• Knowledge of lean ,Six Sigma and root cause analysis.

  具有精益和Six Sigma 概念，和根本原因分析的知识和能力。

• Be capable of hand-on, innovation and learning, and good team worker.

  具有较强的动手能力、良好的创新能力、学习能力及团队协作精神。

• Proficient in Microsoft Office, SolidWork etc.

  能熟练运用office、Project、SolidWork等常用的办公及绘图软件。

• Familiar with FDA/CE regulatory requirements, understand GMP/ASTM/AAMI standards.

  对中国药监局，FDA，CE监管法规和标准熟悉，对ISO/ASTM/AAMI/ 等国际标准有了解。

• Proficient in English language.

  英语听、说、读、写熟练。

  
  

位置：

中国上海

发送邮件到：

hr@wallabymedical.com