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職位描述：

崗位職責(zé)：
1. Be responsible for integrated commissioning, configuration, testing and debugging of hardware and software in the process of new product development. Also provide key technical support for marketed products and production processes.
在新產(chǎn)品開發(fā)過程中負(fù)責(zé)硬件和軟件的聯(lián)合調(diào)試、配置、測(cè)試和調(diào)試工作。同時(shí)也為上市產(chǎn)品和生產(chǎn)過程提供關(guān)鍵技術(shù)支持。

2. Develop test protocols and plans for medical devices to ensure comprehensive coverage of all functions and performance metrics. Propose testing needs, and design corresponding test cases and standards.
制定醫(yī)療設(shè)備的測(cè)試計(jì)劃和測(cè)試大綱，提出測(cè)試需求，設(shè)計(jì)相應(yīng)的測(cè)試用例和測(cè)試規(guī)范，確保測(cè)試活動(dòng)全面覆蓋所有功能和性能指標(biāo)。

3. Study and implement the latest product standards and regulatory requirements, ensuring that both launched and developing products meet relevant standards and regulations.
學(xué)習(xí)并執(zhí)行最新的產(chǎn)品標(biāo)準(zhǔn)和法規(guī)要求，確保已上市產(chǎn)品和研發(fā)中的產(chǎn)品符合相關(guān)法規(guī)和產(chǎn)品技術(shù)標(biāo)準(zhǔn)要求。

4. Verify and validate the complete system, drive defect resolution, conduct tests, and produce test reports, coordinating testing activities throughout the product lifecycle.
對(duì)整機(jī)進(jìn)行驗(yàn)證和確認(rèn)，推動(dòng)缺陷解決，執(zhí)行測(cè)試并出具測(cè)試報(bào)告，統(tǒng)籌產(chǎn)品全生命周期的測(cè)試活動(dòng)。

5. Support type tests, ensuring compliance with registration requirements. Prepare and review medical device registration documentation, ensuring compliance.
支持產(chǎn)品注冊(cè)檢驗(yàn)，編寫并審核醫(yī)療器械注冊(cè)資料，確保產(chǎn)品符合法規(guī)和注冊(cè)要求，確保合規(guī)性。

6. Assist in the management of the R