Qualifications
· Must possess a strong knowledge of engineering disciplines and solid knowledge of related disciplines, Electro/Mechanical, Systems, Fluid Mechanics, Materials Science, etc.
· Strong knowledge of hardware and software systems integration
· A demonstrated track record in electromechanical system development, preferably medical device or other highly regulated products such as military hardware.
· Have a proven track record of management/leadership effectiveness in a fast-paced environment.
· Proven ability to create results within budget, timeline, and product/project deliverables.
· Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international. This includes but is not limited to organizations such as FDA, IEC, ISO, CFDA, and other directives such as RoHS and WEEE. Examples include FDA 21CFR820.30, IEC 60601-1, GB9706, and ISO 14971, etc.
· Understand the requirements of design control, understand Design Verification/Validation, FMEA, DFM.
· Demonstrated ability to communicate and negotiate with all levels of the organization, customers, project sponsors, stakeholders, vendors.
· Comfortable working in a cross-culture environment, teamwork spirit and open minded
· Problem solving skills and can-do attitude required
· Proven ability to effectively manage own time and priorities to meet deadlines
· Good documentation capabilities and presentation skills.
· Strong written, verbal, and interpersonal skills while communicating in both English and Chinese.
· B.S. Or M.S. Degree or Equivalent External Experience
· Major in Computer Science, Electrical, Software engineering or other relevant education background.
Experience should include at least 5-8 years of relevant technical
experience, including some technical leadership
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