Job Duties:
制定與公司產(chǎn)品路線圖相匹配、覆蓋全生命周期的測試驗證總體戰(zhàn)略與總體規(guī)劃。
Develop a comprehensive test verification strategy master plan aligned with the companys product roadmap, covering the entire product lifecycle.
建立覆蓋系統(tǒng)、子系統(tǒng)及部件層的完整測試體系，包括單元測試、集成測試、系統(tǒng)測試、驗證與確認、人因工程可用性測試、動物實驗及臨床前驗證等。
Establish a complete testing system covering system, subsystem, component levels, including unit testing, integration testing, system testing, V&V (Verification & Validation), human factors engineering/usability testing, animal trials, preclinical validation.
主導設(shè)計并持續(xù)優(yōu)化測試流程、規(guī)范、標準操作程序及文檔體系，確保符合醫(yī)療器械質(zhì)量管理體系和法規(guī)要求。
Lead the design continuous optimization of testing processes, standards, standard operating procedures (SOPs), documentation systems to ensure compliance with medical device quality management systems regulatory requirements.
建立并管理缺陷生命周期，主導根本原因分析，與研發(fā)團隊緊密協(xié)作，推動問題高效閉環(huán)。
Establish manage the defect lifecycle, lead root cause analysis (RCA), work closely with R&D teams to drive rapid issue closure.
深度參與設(shè)計評審，從測試與風險角度提供前瞻性輸入。
Actively participate in design reviews, providing forward-looking inputs from testing risk perspectives.
主導產(chǎn)品風險管理活動，確保測試全面覆蓋已識別風險。
Lead product risk management activities (ISO 14971), ensuring testing activities comprehensively cover all identified risks.
負責測試相關(guān)注冊文檔的編寫、審核與歸檔，為產(chǎn)品注冊申報提供可靠測試證據(jù)。
Oversee the preparation, review, archiving of test-related regulatory documentation, providing robust credible test evidence fproduct registrations.
營造嚴謹、務實、注重細節(jié)和安全的團隊文化。
Foster a team culture characterized by rigor, pragmatism, attention to detail, safety awareness.
Qualification:
本科及以上學歷，機器人工程、控制科學與工程、生物醫(yī)學工程、機械電子、計算機科學等相關(guān)專業(yè)。
Bachelors degree above in Robotics Engineering, Control Science Engineering, Biomedical Engineering, Mechatronics, Computer Science, related fields.
8年以上復雜系統(tǒng)（醫(yī)療器械、航空航天、汽車電子等高可靠性領(lǐng)域優(yōu)先）測試或質(zhì)量保證經(jīng)驗，其中至少3年以上團隊管理經(jīng)驗。
Over 8 years of experience in testing quality assurance fcomplex systems (preferably in high-reliability fields such as medical devices, aerospace, automotive electronics), including at least 3 years of team management experience.
具有手術(shù)機器人、醫(yī)用導航設(shè)備、高端有源醫(yī)療器械等領(lǐng)域的完整研發(fā)測試經(jīng)驗者優(yōu)先。
Priexperience with full-cycle R&D testing in surgical robotics, medical navigation devices, high-end active medical devices is preferred.
深刻理解ISO 13485, ISO 14971, IEC 60601, IEC 62304, FDA QSR等。
Deep understanding of ISO 13485, ISO 14971, IEC 60601, IEC 62304, FDA QSR, etc.
掌握自動化測試、白盒/黑盒測試、性能測試、壓力測試等。
Proficiency in automated testing, white-box/black-box testing, performance testing, stress testing, etc.
了解運動學、動力學、控制理論、傳感器、實時系統(tǒng)等基礎(chǔ)知識機器人技術(shù)者佳。
Knowledge of foundational robotics technologies such as kinematics, dynamics, control theory, sensors, real-time systems is advantageous.
能清晰、有力地向技術(shù)團隊和管理層傳達測試發(fā)現(xiàn)與風險并能帶領(lǐng)團隊在壓力下交付任務。
Ability to clearly effectively communicate test findings risks to technical teams management, lead the team to deliver under pressure.
有成功主導支持產(chǎn)品獲得NMPA/FDA/CE注冊上市測試經(jīng)驗者優(yōu)先。
Prisuccessful experience in leading testing efforts to support product registrations (NMPA/FDA/CE) is preferred.