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(cè)試驗(yàn)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(cè)試體系，包括單元測(cè)試、集成測(cè)試、系統(tǒng)測(cè)試、驗(yàn)證與確認(rèn)、人因工程可用性測(cè)試、動(dòng)物實(shí)驗(yàn)及臨床前驗(yàn)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(dǎo)設(shè)計(jì)并持續(xù)優(yōu)化測(cè)試流程、規(guī)范、標(biāo)準(zhǔn)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(dǎo)根本原因分析，與研發(fā)團(tuán)隊(duì)緊密協(xié)作，推動(dòng)問(wèn)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(jì)評(píng)審，從測(cè)試與風(fēng)險(xiǎn)角度提供前瞻性輸入。
Actively participate in design reviews, providing forward-looking inputs from testing risk perspectives.
主導(dǎo)產(chǎn)品風(fēng)險(xiǎn)管理活動(dòng)，確保測(cè)試全面覆蓋已識(shí)別風(fēng)險(xiǎn)。
Lead product risk management activities (ISO 14971), ensuring testing activities comprehensively cover all identified risks.
負(fù)責(zé)測(cè)試相關(guān)注冊(cè)文檔的編寫、審核與歸檔，為產(chǎn)品注冊(cè)申報(bào)提供可靠測(cè)試證據(jù)。
Oversee the preparation, review, archiving of test-related regulatory documentation, providing robust credible test evidence fproduct registrations.
營(yíng)造嚴(yán)謹(jǐn)、務(wù)實(shí)、注重細(xì)節(jié)和安全的團(tuán)隊(duì)文化。
Foster a team culture characterized by rigor, pragmatism, attention to detail, safety awareness.
Qualification:
本科及以上學(xué)歷，機(jī)器人工程、控制科學(xué)與工程、生物醫(yī)學(xué)工程、機(jī)械電子、計(jì)算機(jī)科學(xué)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(fù)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(cè)試或質(zhì)量保證經(jīng)驗(yàn)，其中至少3年以上團(tuán)隊(duì)管理經(jīng)驗(yàn)。
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(jī)器人、醫(yī)用導(dǎo)航設(shè)備、高端有源醫(yī)療器械等領(lǐng)域的完整研發(fā)測(cè)試經(jīng)驗(yàn)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(dòng)化測(cè)試、白盒/黑盒測(cè)試、性能測(cè)試、壓力測(cè)試等。
Proficiency in automated testing, white-box/black-box testing, performance testing, stress testing, etc.
了解運(yùn)動(dòng)學(xué)、動(dòng)力學(xué)、控制理論、傳感器、實(shí)時(shí)系統(tǒng)等基礎(chǔ)知識(shí)機(jī)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(tuán)隊(duì)和管理層傳達(dá)測(cè)試發(fā)現(xiàn)與風(fēng)險(xiǎn)并能帶領(lǐng)團(tuán)隊(duì)在壓力下交付任務(wù)。
Ability to clearly effectively communicate test findings risks to technical teams management, lead the team to deliver under pressure.
有成功主導(dǎo)支持產(chǎn)品獲得NMPA/FDA/CE注冊(cè)上市測(cè)試經(jīng)驗(yàn)者優(yōu)先。
Prisuccessful experience in leading testing efforts to support product registrations (NMPA/FDA/CE) is preferred.