高级工艺工程师

日期:2022-04-06

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, and experienced workers in medical device field is preferred.

    工程类本科以上学历;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, SolidWorks etc.

    能熟练运用office、Project、SolidWorks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 is preferred.

    英语听、说、读、写熟练优先。


位置:

中国上海

发送邮件到:

hr@wallabymedical.com

Wallaby Medical保留所有权利    沪ICP备19039499号-1     沪公网安备 31011502019052号 隐私声明      沃比医疗公众号

Wallaby Medical保留所有权利
沪ICP备19039499号-1     沪公网安备 31011502019052号 隐私声明
沃比医疗公众号