上海励楷科技有限公司
研发工程师(国际业务)
2 months ago
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Important information
Contract type:
Permanent
Location:
Hangzhou, Zhejiang, China
Work mode:
Onsite
Published on:
26 August 2026
What they need
该职位来源于猎聘 1)机械、生物医学工程、高分子材料等相关专业、本科及硕士以上学历,硕士优先; 2) 1-3年三类医疗器械研发经验,有血管介入器械研发经验者优先; 3)熟悉介入类医疗器械产品的设计开发流程,精通ISO13485体系,ISO14971 风险管理的设计研发要求, 有主导欧盟 CE MDR或FDA 510k注册研发项目经验者优先, 4)动手能力强,熟悉结构设计,熟练运用2D、3D设计软件; 5)目标导向,抗压能力强,工作具有主动性和较强的沟通能力; 6)沟通表达清楚,良好的团队意识。 1. 研发样品制作和技术方案 2. 注册项目中设计验证的研发各种资料的撰写 3. 转产项目中研发各种资料的撰写和项目主导 4. 设计变更中研发各种资料的撰写和项目主导
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