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主要職責(zé) – 投訴調(diào)查（影像與導(dǎo)航方向）
● 負(fù)責(zé)醫(yī)療機器人系統(tǒng)中影像與導(dǎo)航子系統(tǒng)的客戶投訴調(diào)查與管理；
● 分析系統(tǒng)日志，執(zhí)行根本原因分析；
● 按照公司流程及法規(guī)要求，撰寫并歸檔調(diào)查報告；
● 開展趨勢分析，識別新的，重復(fù)或系統(tǒng)性問題，并及時上報至研發(fā)團隊；
● 開發(fā)，持續(xù)改進數(shù)據(jù)分析與調(diào)查工具及相關(guān)流程，提高調(diào)查效率與質(zhì)量；
● 與在美國的投訴處理、產(chǎn)品質(zhì)量工程、客戶服務(wù)、臨床工程及影像導(dǎo)航研發(fā)團隊保持緊密協(xié)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(zé) – 環(huán)境與設(shè)備驗證
● 支持醫(yī)院現(xiàn)場新系統(tǒng)的環(huán)境驗證與設(shè)備確認(rèn)；
● 參與C臂影像系統(tǒng)及電磁跟蹤系統(tǒng)的驗證與性能測試；
● 協(xié)助臨床及測試環(huán)境中C臂及影像相關(guān)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(yīng)用科學(xué)本科及以上學(xué)歷，專業(yè)包括但不限于：生物醫(yī)學(xué)工程、電子工程、電氣工程、自動化、系統(tǒng)工程、工業(yè)工程、計算機科學(xué)或應(yīng)用物理；
● 三年以上醫(yī)療器械或相關(guān)高科技行業(yè)設(shè)計，開發(fā)或質(zhì)量工程類工作經(jīng)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(yōu)秀的英文書寫能力，能夠獨立完成技術(shù)文檔與調(diào)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(yī)院客戶進行高效協(xié)作；
● 思維清晰、邏輯嚴(yán)謹(jǐn)，具備科學(xué)的分析方法與判斷能力；
● 善于溝通，能夠清楚地解釋復(fù)雜問題，表達(dá)條理清晰；
● 執(zhí)行力強，能夠合理規(guī)劃任務(wù)并高效完成工作目標(biāo)；
● 關(guān)注細(xì)節(jié)，嚴(yán)謹(jǐn)認(rèn)真，責(zé)任心強，耐心細(xì)致，能夠同時處理多項調(diào)查任務(wù)。
優(yōu)先條件
● 具有醫(yī)學(xué)影像、X射線影像、圖像質(zhì)量或醫(yī)學(xué)導(dǎo)航系統(tǒng)相關(guān)經(jīng)驗；
● 擁有醫(yī)療器械公司設(shè)計或質(zhì)量工程經(jīng)驗者優(yōu)先：如設(shè)計控制、風(fēng)險分析、上市后監(jiān)督、或投訴調(diào)查；
● 熟悉JIRA、電子投訴管理系統(tǒng)及標(biāo)準(zhǔn)質(zhì)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.