公司平台：士卓曼旗下联耀医疗
This role is based in Alliedstar, a company acquired by Straumann Group.
关于联耀医疗
ABOUT ALLIEDSTAR
作为牙科专业人士信赖的合作伙伴，联耀致力于通过技术创新提供高效、可靠的数字化解决方案，以适应不同的临床需求，最终帮助口腔诊室提升诊疗体验，在实践中追求卓越。
As a trusted partner for dental professionals, Alliedstar strives to deliver intuitive and reliable digital solutions by advancing technology around clinical demands. We empower dental enthusiasts to level up patient care and achieve excellence in their everyday practice.
我们的使命是坚持引领创新，为牙科专业人士提供先进易用的数字化解决方案，成就更多人的高品质生活。
Our mission is to enrich lives with innovative and easy-to-use digital solutions for dental professionals.
主要工作职能：
Major Responsibilities:
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独立负责：独立负责产品设计开发阶段的质量策划，制定硬件部分的设计验证与确认计划与方案。
Independent Responsibility: Independently oversee quality planning during the product design and development phase, formulating design verification and validation plans and protocols for hardware. -
主导评审：独立完成硬件部分的设计输入评审，参与硬件概要设计与详细设计等评审，识别潜在风险并提出改进建议。
Lead Reviews: Independently complete design input reviews for product hardware, participate in reviews of hardware high level design and low level design, identifying potential risks and proposing improvement suggestions.
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测试执行：参与制定基于风险的硬件测试策略，搭建复杂的硬件测试环境，编写测试用例，执行测试并记录测试结果。
Test Execution: Contribute to risk-based hardware testing strategies, set up complex hardware test environments, write test cases, execute tests, and record results. -
问题解决：协助开发人员对已识别的缺陷进行根本原因分析，编写测试报告，跟踪问题解决并验证问题闭环。
Issue Resolution: Assist developers in root cause analysis for identified defects, compile test reports, track issue resolution, and verify issue closure. -
变更管理：参与硬件设计变更的评审，对变更进行验证与确认，确保变更不会引入新的风险。
Change Management: Participate in the review of hardware design changes, verify and validate the changes, ensuring changes do not introduce new risks. -
法规跟踪：跟踪国内外医疗器械相关法规和标准的最新动态，及时调整公司硬件设计验证与确认策略。
Regulatory Tracking: Stay updated on the latest developments in domestic and international medical device regulations and standards, promptly adjusting the company's hardware design verification and validation strategies.
任职要求：
Requirements:
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本科及以上学历，电子工程、自动化、通信工程等相关专业。
Bachelor's degree or higher in Electronic Engineering, Automation, Communication Engineering, or related fields. -
3~5年医疗器械行业硬件开发或测试经验，熟悉医疗器械相关法规和标准。
3~5 years of experience in hardware development or testing in the medical device industry, familiar with relevant regulations and standards. -
熟悉光学、机械、电子、嵌入式系统等硬件知识，掌握至少一个领域的硬件测试方法，熟悉常用硬件测试工具。
Familiar with hardware knowledge such as optics, mechanics, electronics, embedded systems, etc., proficient in hardware testing methods in at least one area, and familiar with commonly used hardware testing tools. -
具备英语读写能力，能够阅读和理解英文技术文档。
Proficiency in English reading and writing, able to comprehend English technical documents.
