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- Decompose the regulatory requirements as an input of system design, especially on EMC and Safety. Verify the compliance in the consequent development stages.
- Establish and maintain relationship with the 3rd party testing labs (SGS, CSA, etc.), and lead the 3rd party tests for product regulatory submission, such as CE, NRTL, KC, etc.
- Ensure that the product continuously and effectively meets the requirements of safety and regulations and facilitate risk management process in compliance to appropriate external standards and corporate policies.
- Work with Electronics/mechanical/optical engineer to develop types of test methods (e.g. reliability, EMC, safety, environment, worst case).
- Support of complaint investigations ，especially for risk assessment and analysis etc.
- Work with team to ensure the design/manufacture transfer successfully
- Support the NMPA registration and other related works.
- Other duties, as assigned.
Education / 教育背景
BS in Electronics/Mechanics/optic engineering.
Experience / 经验
3+ years working experience in tests of EMC & safety. Working experience in a R&D environment is a plus.
Be familiar with risk management and biocompatibility would be preferred.
Good comprehension of IEC 60601-1, IEC 60601-1-2, GB9706.1, GB9706.102. Be familiar with IEC 60601-1-9, usability, PEMS and RF standards. Have knowledge of Global Market Admission is advantageous.
Experience in Class II medical devices in highly desired.
Other skills /其他技能
- Competent and experienced in the use of Excel, Word.
- Detail orientated and concentrated working style.
- Creativity, one’s own initiative, analytical skills and judgment.
- Strong oral and written English, professionalism in representing his/her work.
- Excellent communication, teamwork and problem-solving skills
- Occasional overtime work might be necessary.
Your ZEISS Recruiting Team:
Jingwen Mao （毛静文）, Xiaojun Yang （杨晓君）, Xiaowei Yun （恽晓玮）
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