System Engineer
Report :Engineering Director
Department: China Innovation and R&D Center

？Work with Marketing, Quality, Regulatoy and Engineering to define, analyze, detail, and document specifications for performance, features, controls, and operation of products into a form suitable for product implementation,
？provide technical support on product CFDA/FDA registration, generate documentation of requirements and traceability matrices need to be maintained for regulatory purposes;
？lead system integration of the specialist areas of a product;
？plan and conduct in-depth reviews, testing and verifications/validation of product features, critically analyze and verify system performance
？specify and develop improvements or enhancements to existing products and champion implementation if necessary,
？handle other duties as needed

Education
？Master degree in bioengineering, optics, mechanics mechatronics, or similar engineering disciplines; or BS in Engineering with 5+ years directly related working experience in product development of medical devices.

Experience
？Two or more (2+) years of medical industry experience;
？Familiar with Medical device standards and regulations;
？The candidate should demonstrate the knowledge in product development of medical devices.

Other Skills
Excellent communication (oral and written in English) and teamwork skills;
Strong analytic and problem solving skills;
Competent and experienced in the use of IT tools, such as Excel, Word, MS Project

上班地址：上海