工艺工程师(介入类)

日期: 2021-03-30

岗位职责:

1.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。

2.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

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

有实施IQ/OQ/PQ/PPQ的经验

4.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。

5.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。

6.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

7.Design and maintain the tooling and equipment.

工装夹具和设备的设计及维护。

8.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。

9.Experienced in data analysis and statistics.

分析数据, 有实用性的统计学知识

岗位要求:

1.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;

2.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

3.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

4.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;

5.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;

6.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;

7.Proficient in English language.

英语听、说、读、写熟练。

位置:

上海

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