医疗器械认证工程师

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医疗器械认证工程师 0.8-1万/月/月

广州尚宸企业管理顾问有限公司

广州

本科
03-10 发布

职位信息

职位名称：医疗器械认证工程师

类别名称：

职位描述：

职位描述：JOB RESPONSIBILITIES:- Perform safety evaluation on products according to the US, Canadian and/or international safety standards, write up test reports as well as evaluation result reports;- Perform L&HS related services including and not limited to HFE, PEMS, RM.- Independently manages execution and timely completion of engineering projects by analyzing project scope and determining project specifications, establishing test programs for product investigations, and preparing reports for clients;- Responsible for opening, maintenance, completion, and closing of assigned new work engineering projects which includes frequent travel to conduct or witness tests at client sites;- Participates in the development of company requirements, test methods, and test equipment;- May directs and review work of assigned staff. May train office, field, and/or laboratory staff and entry-level engineers. Provides technical assistance to laboratory and/or field staff.- Work closely with customers from China and other Asia countries throughout the product safety evaluation process.- Preform all ad hoc tasks assigned by the manager.REQUIREMENTS:- Degree in Electrical / Electronic Engineering /Sciences or equivalents with at least 3-5 years relevant experiences;- The following majors are highly preferred: biomedical engineering, electrical engineering, automation, physics or similar major.- Knowledge in medical standard (60601-1) and laboratory equipment (61010-1) is a must. Knowledge about part two standard including Patient Monitor, Ultrasound, ECG, X-ray and related medical equipment, or Personal Hygiene Device (1431) is an advanced.- Candidate with less experience will be considered as Engineer.- Strong sense of customer focus, good interpersonal and communication skills.- Good command of spoken and written English, Cantonese and Putonghua;- Willing to travel.- Be able to work under stressful environment.- Self pro-active in problem solving.

任职要求：

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