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更新于 10月31日

產品質量工程師-R&D(需具備研發(fā)、測試經驗)

1.2-2.4萬
  • 天津東麗區(qū)
  • 3-5年
  • 本科
  • 全職
  • 招1人

職位描述

三類醫(yī)療器械ISO13485
主要職責 – 投訴調查(影像與導航方向)
● 負責醫(yī)療機器人系統(tǒng)中影像與導航子系統(tǒng)的客戶投訴調查與管理;
● 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,撰寫并歸檔調查報告;
● 開展趨勢分析,識別新的,重復或系統(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(fā)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(huán)境與設備驗證
● 支持醫(yī)院現場新系統(tǒng)的環(huán)境驗證與設備確認;
● 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;
● 協助臨床及測試環(huán)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(yè)包括但不限于:生物醫(yī)學工程、電子工程、電氣工程、自動化、系統(tǒng)工程、工業(yè)工程、計算機科學或應用物理;
● 三年以上醫(yī)療器械或相關高科技行業(yè)設計,開發(fā)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(yōu)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(yī)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(zhí)行力強,能夠合理規(guī)劃任務并高效完成工作目標;
● 關注細節(jié),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(yōu)先條件
● 具有醫(yī)學影像、X射線影像、圖像質量或醫(yī)學導航系統(tǒng)相關經驗;
● 擁有醫(yī)療器械公司設計或質量工程經驗者優(yōu)先:如設計控制、風險分析、上市后監(jiān)督、或投訴調查;
● 熟悉JIRA、電子投訴管理系統(tǒng)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.

工作地點

天津市-東麗區(qū)-弘泰道華明低碳產業(yè)基地

職位發(fā)布者

張女士/HR

立即溝通
公司Logo天津普利方舟醫(yī)療科技有限公司
天津普利方舟醫(yī)療科技有限公司(以下簡稱“普利方舟醫(yī)療”)是一家美國企業(yè)在中國的全資子公司。普利方舟醫(yī)療旨在以新一代科技開創(chuàng)醫(yī)療機器人新紀元。我們正在研制全新一代的醫(yī)療機器人平臺,針對多種適應癥的患者進行早期診斷和治療。普利方舟醫(yī)療與美國母公司現已擁有超過300人的研發(fā)團隊,包括工程師、創(chuàng)新者和行業(yè)先驅者在內的多位專家學者。我們不但擁有行業(yè)先進的技術,更具備來自世界優(yōu)秀醫(yī)療公司的多年經驗,敏銳的洞察力以及豐富的創(chuàng)造力。普利方舟醫(yī)療期待更多杰出的工程師和關鍵團隊成員的加入。我們期待有才華,有進取心且雄心勃勃的優(yōu)秀人才加入我們的團隊。期望在我們的共同努力下,打造出革命性的新一代手術機器人產品,造福于人類。
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