明基集团
工艺工程师
2 months ago
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Important information
Contract type:
Permanent
Location:
Shanghai, China
Work mode:
Onsite
Published on:
29 August 2026
What they need
该职位来源于猎聘 岗位职责: 1.负责三类医疗器械产品从设计验证到量产的全流程工艺开发,确保产品符合医疗器械质量管理体系要求 2.主导工艺验证和过程确认,完成至少2个三类医疗器械产品的工艺转移项目 3.优化生产工艺流程,将产品一次合格率提升至98%以上 4.编制工艺文件和技术标准,确保生产操作规范符合GMP和ISO13485体系要求 任职要求: 1.本科及以上学历,生物医学工程、机械工程或相关专业背景 2.具备5年以上三类医疗器械生产工艺经验,熟悉无菌医疗器械生产要求 3.精通工艺验证、过程确认和风险管理,掌握FMEA等质量工具应用 4.熟悉医疗器械法规体系,有通过FDA或NMPA现场检查经验者优先
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