主要職責 – 投訴調查（影像與導航方向）
● 負責醫療機器人系統中影像與導航子系統的客戶投訴調查與管理；
● 分析系統日志，執行根本原因分析；
● 按照公司流程及法規要求，撰寫并歸檔調查報告；
● 開展趨勢分析，識別新的，重復或系統性問題，并及時上報至研發團隊；
● 開發，持續改進數據分析與調查工具及相關流程，提高調查效率與質量；
● 與在美國的投訴處理、產品質量工程、客戶服務、臨床工程及影像導航研發團隊保持緊密協作。
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.
次要職責 – 環境與設備驗證
● 支持醫院現場新系統的環境驗證與設備確認；
● 參與C臂影像系統及電磁跟蹤系統的驗證與性能測試；
● 協助臨床及測試環境中C臂及影像相關問題的排查與診斷。
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
任職要求： Requirements
基本要求
● 工程或應用科學本科及以上學歷，專業包括但不限于：生物醫學工程、電子工程、電氣工程、自動化、系統工程、工業工程、計算機科學或應用物理；
● 三年以上醫療器械或相關高科技行業設計，開發或質量工程類工作經驗；
● 具備扎實的分析與問題解決能力，熟悉根本原因分析方法；
● 優秀的英文書寫能力，能夠獨立完成技術文檔與調查報告；
● 良好的中英文口頭溝通能力，能夠與美國及中國團隊以及醫院客戶進行高效協作；
● 思維清晰、邏輯嚴謹，具備科學的分析方法與判斷能力；
● 善于溝通，能夠清楚地解釋復雜問題，表達條理清晰；
● 執行力強，能夠合理規劃任務并高效完成工作目標；
● 關注細節，嚴謹認真，責任心強，耐心細致，能夠同時處理多項調查任務。
優先條件
● 具有醫學影像、X射線影像、圖像質量或醫學導航系統相關經驗；
● 擁有醫療器械公司設計或質量工程經驗者優先：如設計控制、風險分析、上市后監督、或投訴調查；
● 熟悉JIRA、電子投訴管理系統及標準質量文檔管理流程。
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.