高级产品质量工程师 – 影像与导航方向(英语工作)

该职位来源于猎聘 主要职责 – 投诉调查(影像与导航方向)

• 负责医疗机器人系统中影像与导航子系统的客户投诉调查与管理;
• 分析系统日志,执行根本原因分析;
• 按照公司流程及法规要求,撰写并归档调查报告;
• 开展趋势分析,识别新的,重复或系统性问题,并及时上报至研发团队;
• 开发,持续改进数据分析与调查工具及相关流程,提高调查效率与质量;
• 与在美国的投诉处理、产品质量工程、客户服务、临床工程及影像导航研发团队保持紧密协作。 Primary – Complaint Investigation (Imaging & Navigation)
• Manage and perform complaint investigations related to imaging and navigation subsystems of a medical robotic system
• Analyze system logs, and perform root cause analysis
• Draft and document investigation reports in compliance with company procedures and regulatory requirements
• Perform trend analysis, identify new, recurring or systemic issues, and promptly escalate them to R&D for further action
• Develop and continuously improve data analytics and investigation tools and related processes to enhance investigation efficiency and quality Work closely with US-based teams, including Complaint Handling, Product Quality Engineering, Customer Service Representative, Clinical Engineering, and Imaging & Navigation R&D teams. 次要职责 – 环境与设备验证
• 支持医院现场新系统的环境验证与设备确认;
• 参与C臂影像系统及电磁跟踪系统的验证与性能测试;
• 协助临床及测试环境中C臂及影像相关问题的排查与诊断。 Secondary – Environmental & Equipment Validation
• Support environmental validation and equipment qualification for new systems in hospitals
• Participate in validation of new C-arm imaging systems and electromagnetic tracking systems
• Assist with troubleshooting C-arm and imaging-related use issues in clinical and test environments 任职要求: Requirements 基本要求
• 工程或应用科学本科及以上学历,专业包括但不限于:生物医学工程、电子工程、电气工程、自动化、系统工程、工业工程、计算机科学或应用物理;
• 三年以上医疗器械或相关高科技行业设计,开发或质量工程类工作经验;
• 具备扎实的分析与问题解决能力,熟悉根本原因分析方法;
• 优秀的英文书写能力,能够独立完成技术文档与调查报告;
• 良好的中英文口头沟通能力,能够与美国及中国团队以及医院客户进行高效协作;
• 思维清晰、逻辑严谨,具备科学的分析方法与判断能力;
• 善于沟通,能够清楚地解释复杂问题,表达条理清晰;
• 执行力强,能够合理规划任务并高效完成工作目标;
• 关注细节,严谨认真,责任心强,耐心细致,能够同时处理多项调查任务。 优先条件
• 具有医学影像、X射线影像、图像质量或医学导航系统相关经验;
• 拥有医疗器械公司设计或质量工程经验者优先:如设计控制、风险分析、上市后监督、或投诉调查;
• 熟悉JIRA、电子投诉管理系统及标准质量文档管理流程。 Required
• Bachelor's degree in engineering of applied science — Biomedical, Electronic, Electrical, Automation, Systems, Industrial, Computer Science, or Applied Physics.
• Minimum 3 years in design, development or quality engineering within the medical device industry or related high-tech fields.
• Strong analytical and problem-solving skills, including experience with root cause analysis (RCA).
• Excellent written communication in English (for documentation and reporting).
• Strong verbal communication in both English and Chinese, enabling effective collaboration with U.S. and China-based teams, as well as potential communication with hospital staff.
• Clear thinker with logical and scientific reasoning; demonstrates structured analysis and sound judgement
• Communicates clearly and can explain complex problems in a concise and organized way.
• Strong execution and task management skills -- able to plan, prioritize, and complete work efficiently.
• Detail-oriented, rigorous, responsible, and patient, and the ability to manage multiple investigations concurrently. Preferred
• Prior experience in medical imaging, X-ray imaging, image quality, or navigation systems.
• Experience in design or quality engineering within a regulated medical device company (such as design controls, risk analysis, post-market surveillance, or complaint investigations).
• Familiarity with tools such as JIRA, electronic complaint management systems, and standard quality documentation practices.