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.