工作职责：

1. Develop, update, and maintain technical documentation for medical devices (e.g., Instructions for Use (IFUs), Service Manuals, Design Change notice), ensuring content accurately reflects product technical status.
编写、更新和维护医疗器械技术文档（如使用说明书、服务手册、设计变更文档等），确保内容准确反映产品技术状态。

2. Manage multilingual translation processes (including editing, review, and localization) to meet regulatory and marketing requirements in target markets.
管理多语言翻译流程（包括编辑、审核与本地化），满足目标市场的法规及营销需求。

3. Collaborate closely with R&D engineers, project leaders, Regulatory Affairs, Risk Management, and Product Development teams to ensure technical accuracy and compliance of documentation.
与研发工程师、项目负责人、注册事务、风险管理及产品开发团队紧密协作，确保文档技术准确性与合规性。

4. Monitor and implement regulatory standards (e.g., ISO 13485, IEC 62366, NMPA, FDA, MDR) to ensure global compliance of documentation.
跟踪并实施ISO 13485、IEC 62366、NMPA、FDA、MDR等法规标准，确保文档符合全球监管要求。

5. Integrate feedback from stakeholders, continuously update document versions, and manage end-to-end document lifecycle control.
整合各方相关方反馈，持续更新文档版本，管理全生命周期文档控制。

6. Create screenshot sets and visual materials for Instructions for Use and Service Manuals of medical devices.
制作医疗器械使用说明书及服务手册所需的截图集与可视化内容。

7. Utilize ERP systems, Product Lifecycle Management (PLM) tools, MS Office, and related software to efficiently complete documentation tasks.
使用ERP系统、PLM工具、MS Office等软件高效完成文档任务。

任职要求：

1. Bachelor’s degree in biomedical engineering, Electronic Information Engineering, Automation, Mechatronics, Industrial Design, or related engineering fields, with 3+ years’ experience in medical device or pharmaceutical Industry.
生物医学工程、电子信息工程、自动化控制、机电工程、工业设计等相关工科专业本科，3年以上医疗器械或药物行业经验。

2. Excellent English proficiency (written/spoken) for documentation and cross-border communication.
优秀英文书面与口语能力（必备），可独立撰写合规文档及跨国沟通。

3. Familiar with medical device development processes and quality management workflows.
熟悉医疗器械开发流程及质量管理体系运作。

4. Strong attention to detail, ability to manage multiple tasks under deadlines, and cross-functional collaboration/analytical skills.
高度注重细节，能在时限内高效处理多任务，具备跨团队协作与逻辑分析能力。

5. Experience in agile development or multinational teams preferred; Master’s degree or large-scale medical equipment documentation experience is a plus.
具备敏捷开发或跨国团队经验者优先；硕士学历或大型医疗设备文档经验者优先。

6. Proficiency in documentation tools such as Microsoft Word, Google Docs, etc., Adobe, as well as document control system Apps.
熟练掌握微软 Word、谷歌文档、Adobe 等文档处理工具以及文控软件。