職位描述
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崗位職責:
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.
在新產品開發過程中負責硬件和軟件的聯合調試、配置、測試和調試工作。同時也為上市產品和生產過程提供關鍵技術支持。
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.
制定醫療設備的測試計劃和測試大綱,提出測試需求,設計相應的測試用例和測試規范,確保測試活動全面覆蓋所有功能和性能指標。
3. Study and implement the latest product standards and regulatory requirements, ensuring that both launched and developing products meet relevant standards and regulations.
學習并執行最新的產品標準和法規要求,確保已上市產品和研發中的產品符合相關法規和產品技術標準要求。
4. Verify and validate the complete system, drive defect resolution, conduct tests, and produce test reports, coordinating testing activities throughout the product lifecycle.
對整機進行驗證和確認,推動缺陷解決,執行測試并出具測試報告,統籌產品全生命周期的測試活動。
5. Support type tests, ensuring compliance with registration requirements. Prepare and review medical device registration documentation, ensuring compliance.
支持產品注冊檢驗,編寫并審核醫療器械注冊資料,確保產品符合法規和注冊要求,確保合規性。
6. Assist in the management of the R
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.
在新產品開發過程中負責硬件和軟件的聯合調試、配置、測試和調試工作。同時也為上市產品和生產過程提供關鍵技術支持。
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.
制定醫療設備的測試計劃和測試大綱,提出測試需求,設計相應的測試用例和測試規范,確保測試活動全面覆蓋所有功能和性能指標。
3. Study and implement the latest product standards and regulatory requirements, ensuring that both launched and developing products meet relevant standards and regulations.
學習并執行最新的產品標準和法規要求,確保已上市產品和研發中的產品符合相關法規和產品技術標準要求。
4. Verify and validate the complete system, drive defect resolution, conduct tests, and produce test reports, coordinating testing activities throughout the product lifecycle.
對整機進行驗證和確認,推動缺陷解決,執行測試并出具測試報告,統籌產品全生命周期的測試活動。
5. Support type tests, ensuring compliance with registration requirements. Prepare and review medical device registration documentation, ensuring compliance.
支持產品注冊檢驗,編寫并審核醫療器械注冊資料,確保產品符合法規和注冊要求,確保合規性。
6. Assist in the management of the R
工作地點
地址:朝陽龍城區聯合金融大廈-A座
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職位發布者
阮燕平HR
深圳市慧康醫療器械有限公司

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醫療設備·器械
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200-499人
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私營·民營企業
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福田保稅區