GE BUSINESS NAME : GE Healthcare BUSINESS / DIVISION DESCRIPTION : GEHC: Clinical Systems LOCATION / DIVISION 2 : GEHC: Clinical Systems LOCATION / DIVISION 3 : GEHC: Clinical Systems FUNCTIONAL WORK AREA : Quality
ESSENTIAL FUNCTION / RESPONSIBILITIES:
产品的安全符合性,确保产品满足国内外标准。
产品研发中的安全风险分析,安全风险管理和控制,以及安全设计要求。
产品全球上市的法规符合性,各国市场准入。
国内国际标准和法规的了解和熟悉,并运用实施。
安全测试和EMC测试.
客户投诉的安全问题风险分析,事故报告。
产品设计更改的安全法规评估,样品安全评估,FMI 安规评估及政府报告.产品含: 新研发产品,升级产品,转移产品(转入和转出)
QUALIFICATIONS / REQUIREMENTS:
满足GEHC的质量和安全目标。
参加所有要求的环境安全健康培训, 和相关活动。
作为团队一员遵循公司规定, 和工厂安全规章。
本科或以上学历, 电子工程或相关专业, 有二年或两年以上相关的工作经验.
具有安全法规方面的经验,熟悉有关医疗设备的法规要求.
具有较强的学习能力, 思维清晰, 工作效率高.
具有积极,主动和高度认真负责任的工作态度.
具有良好的英文书写和口语能力.
具有团队合作精神和良好的沟通能力.
DESIRED:
硬件工程师背景.
熟悉医疗器械国内国际标准,CE/FDA/MHLW法规.
了解WEEE/RoHS
EMC 要求及测试和调试
GENERAL DESCRIPTION: GE Healthcare provides transformational medical technologies that are shaping a new age of patient care. GE Healthcare‘s expertise in medical imaging and information technologies, medical diagnostics, patient monitoring and life support systems, disease research, drug discovery, and biopharmaceutical manufacturing technologies is helping physicians detect disease earlier and to tailor personalized treatments for patients. GE Healthcare offers a broad range of products and services that are improving productivity in healthcare and enhancing patient care by enabling healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions. Headquartered in the United Kingdom, GE Healthcare is a $15 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 43,000 people committed to serving healthcare professionals and their patients in more than 100 countries.GE is an equal opportunity employer.
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