医疗产品测试研发工程师 R&D Project Engineer

测试技术开发

• Responsible for the research and development of testing technology for medical device products, including the conversion of standards, the creation of new equipment tooling, and the development of new testing methods
• 负责医疗器械产品测试技术的研发，包括标准的转化，新的设备工装的制作、新的测试方法的开发
• Develop plans and technical solutions for product testing methods based on user and market needs
• 根据用户需求和市场需求，制定产品测试方法的开发计划及技术方案
• Research new medical device technologies, track industry technology trends, and promote innovations in testing technology
• 研究新型医疗器械技术，跟踪行业技术动态，推动测试技术创新
• Improve existing testing methods and tooling to enhance testing efficiency, accuracy, and reliability
• 对现有测试方法和工装进行改进，提升测试效率，测试的准确性和可靠性

实验与测试

• Participate in experiments to validate the developed testing methods and tooling, ensuring that tests meet relevant standards and regulatory requirements
• 参与验证所开发的测试方法和工装的实验，确保测试符合相关标准和法规要求
• Analyze experimental data, solve technical problems, and optimize testing methods and equipment tooling designs
• 分析实验数据，解决技术问题，优化测试方法和设备工装设计

文档编写

• Write testing procedures, test reports, and related technical documentation
• 编写测试规程、测试报告和相关技术资料
• Collaborate with the quality system to complete the writing and review of testing technical documents
• 配合质量体系，完成测试技术文件编写和审核

团队协作

• Work with cross-departmental teams (such as sales and auditing) to drive the entire process of testing from R&D to market
• 与跨部门团队（如销售、审核）协作，推动测试从研发到市场的整个流程
• Participate in project meetings to report on R&D progress and technical issues
• 参与项目会议，汇报研发进展和技术问题

合规性与法规

• Ensure that the design and development of the developed testing methods and testing equipment tooling comply with domestic and international medical device regulatory requirements
• 确保所开发的测试方法和测试设备工装等的设计和开发符合国内外医疗器械法规要求
• Assist in laboratory certification work including ISO 17025
• 协助ISO 17025在内的实验室认证工作

支持医疗产品认证部门进行测试领域战略规划

完成本地业务经理分配的其他工作

• Master's degree or above, with a specialization in Biomedical Engineering, Computer Science, Electronic Information Engineering, Mechatronics, or related fields
• 硕士及以上学历，专业方向为生物医学工程，计算机，电子信息工程，机电一体化或相关专业
• Senior Engineer title or above, specializing in the medical device field is preferred
• 专业方向为医疗器械领域副高级工程师或以上职称者优先
• Over 6 years of laboratory work experience, with preference given to those with medical laboratory experience
• 6年以上实验室工作经验，有医疗实验室工作经验者优先
• Participation in the establishment of laboratory quality management systems, familiar with CNAS, CMA, ISO 17025 and other requirements
• 参与实验室质量管理体系建设，熟悉CNAS、CMA、ISO 17025等要求
• Those with work experience of holding an invention patent (excluding utility models) as the first inventor are preferred.
• 有一项作为第一发明人的发明专利（不含实用新型）的工作经历者优先
• Those who have participated as the main drafter in the development of one industry standard or more than two group standards are preferred
• 作为主要起草人参与制定1个行业标准或者2个以上的团体标准者优先
• Familiar with the use of office software and databases
• 熟悉office办公软件和数据库的使用
• Proficient in English, particularly in reading and writing
• 英文熟练，尤其读写能力
• Strong communication and coordination skills
• 良好的沟通协调能力