东莞招聘

Clinical Engineer Manager(美国医疗设备行业巨头，新建亚太区研发中心，薪资优厚，有海外培训机会)

Reporting line:
R&D department, Tailor Product Director

Subordinates:
Temporary Not directly, but will lead external resource for clinical activity

Duties and Responsibilities:
——Represents the Tailored R&D team on new product development programs and other multi-functional teams; Applies clinical thinking into deep engineering feasibility study with cross-functional team

——Establish relationships with Key Opinion Leaders to drive project(s) forward and prototype verification with those KOLs.

——Independently develops Clinical Validation Strategies, Clinical Study Plans, and Clinical Protocols to evaluate the accuracy and clinical performance/acceptance of tailored products prior to product release.

——Conducts and observes product testing and operation of equipment at customer/clinical sites, and is responsible for the accuracy, completeness and regulatory compliance of all clinical study results for their assigned programs.

——Applies advanced understanding of SFDA regulations and international standards under which clinical studies of medical devices are conducted.

Job Qualification:

Education:

Master’s Degree in /Medical/Health/Engineering related field required.

Experience:
5-8 years working experience within surgeon and engineering preferred as following:
——3-5 years of working experience, preferably as Surgeon in hospital
——3-5 years of working experience as design engineer or clinical engineer in medical device company as a plus

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