1. 协助开展新产品开发与系统改进项目，协调质量、法规、生产及海外团队，保障项目执行与交付；负责部分新产品供应商沟通对接，参与编写验证协议（IQ/OQ/PQ）及技术文档，确保符合 ISO 13485 等法规标准及内部质量体系要求。
Coordinate new product development and system improvement projects, conduct cross-functional coordination with quality, regulatory, production and overseas teams to support project execution and delivery, manage communication with new product suppliers, participate in the writing of verification protocols (IQ/OQ/PQ) and technical documents, and ensure compliance with regulatory standards such as ISO 13485 and internal quality system requirements.

2. 深入参与研发与新产品开发流程，协助编写及整理体系要求的设计相关文件（如设计输入、设计输出、评价等），确保满足体系规范。
Deeply involved in the R&D and new product development processes, providing material, process and technical advice from the conception stage, promoting the application of innovative and sustainable materials, collaborating with the procurement department to optimize the supplier network, reducing supply chain risks and costs, and supporting supplier relationship management and contract negotiations.

3. 负责日常邮件处理、会议组织及临时事项的跟进与改进工作，推动现有产品、生产工艺与材料的质量提升。
Responsible for handling daily emails, meetings and following up on temporary matters for improvement, promoting the quality enhancement of existing products, processes and materials, introducing alternative materials and processes to improve quality and profits, and leading related projects such as increasing the proportion of internal manufacturing.

4. 协助开展公司内外部审核工作，积极跟进不符合项的整改与闭环处理，确保研发部门体系持续合规；有效响应监管机构要求，及时编制、更新并维护研发产品相关法规文件。
Assist the internal and external audit work of the company, actively follow up on the improvement and closed-loop handling of non-conformities, ensure the continuous compliance of the quality management system, and effectively respond to the requirements of regulatory authorities. Timely prepare, update and maintain relevant regulatory documents.

5. 协助推进产品与过程的变更申请、等同性报告、风险评估等体系文件的编制与完善工作，确保医疗器械的安全性、有效性及合规性。
Be responsible for the daily operation and maintenance of the quality management system, take the lead in conducting risk assessments of products and processes, ensure the safety, effectiveness and compliance of medical devices, and promote the implementation of relevant follow-up measures.

6. 随着公司持续发展与进步，个人接受公司对本研发岗位职责的必要调整与优化，并积极配合执行。
As the company continues to develop and progress, person should accept any necessary adjustments and optimizations of the job responsibilities made by the company at any time and actively cooperate.

岗位需求：

1、具体相关经验

2、熟练的工作英文语言交流

3、责任心强，优秀的职业道德和职业操守

4、福利待遇优，弹性工作制