Senior System Engineer

Job description

 

Job responsibilities:

  • Support CFDA submission for one of Surgical’s new product
  • Coordinate pre-testing activities in Sunnyvale to ensure compliance with Chinese standards
  • Be part of small core team that will write PTR for CFDA submission
  • Resolve design issues related to instrument or robot mechanics, electro-mechanical controls, and software
  • Investigate and determine root cause of both latent and emerging defects in the existing population of deployed systems
  • Tasks are related to issues found in the field or Manufacturing that require engineering investigation and redesign, including formal design verification testing
  • Work in cross-functional teams to ensure all issues related to a design change are understood in advance of implementation
  • Develop, implement, test and document solutions for issues according to corporate standard and departmental operating procedures

 

Requirements:

  • MS or Doctorate in CS, EE, ME, or similar, and at least 5 years industrial experience
  • Strong educational emphasis on control theory and practice
  • Expertise in the practical implementation of tele-robotic systems, (e.g. experience with real time control systems, multi-tasking, embedded operating systems, etc.)
  • Strong ability to isolate and debug mechanical, embedded hardware and software problems
  • Excellent communication (written, oral), presentation and documentation skills
  • Comfortable with all phases of the product development lifecycle including design, implementation, debug, verification, qualification, and transfer 
  • Experience with designing in an CFDA or other regulated industry or for mission critical applications is desired; comfort with concepts of design input, design output, traceability, and risk analysisA passion for creating robust and reliable products
  • Broad and deep understanding of:
    Requirement Management and Medical Devices Design Controls regulations (FDA CFR/QSIT, MDR, ISO 13485, ISO 14971, CFDA)
  • Third party agency testing (UL, EMC, biocompatibility, sterilization assurance) in both US and China
  • Fluent in mandarin and English (read/write), able to travel to US up to 30%

 

13 Jul, 2018
Shanghai
Full Time
Hershey Zhou
hershey.zhou@lloydmorgan.com.cn
+86 512 6255 8553