CT System Engineer

Description:

The CT System Engineer will work with a cross functional project team to deliver the CT products in China. This position has design responsibilities to localize the global CT products, integrate & validate a functional prototype to deliver the desired workflow, features & functionalities, and accelerate the NMPA registration. Activities include design requirements development and verification, architecture / system design and analysis, FMEA, developing/executing System Verification and Validation procedures, and take lead in supplier interactions and regulation registration.

Duties include (but are not limited to):

• Participate system design and integration of the hardware and software sub-systems under development, to achieve the desired functions & quality targets;
• Drive supplier interactions on trouble shooting and solve problems during the system integration and clinical evaluation.
• Working with customers, Marketing and the related project teams to refine and validate the design specifications.
• System NMPA registration activities.

Quality Specific Goals:

1. Aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Support compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables
5. Participate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible

Qualifications:

1. BS or above with major in Electrical engineering, Automation engineering, Physics, or Telecommunications engineering.
2. At least 3 years of relevant working experience in hardware design & system integration.
3. Familiar with trouble shooting in hardware/software integrations with proven ability to develop timely and effective solutions for challenging design problems
4. Basic knowledge in CT or sound knowledge in medical device industry
5. Familiar with key design areas: controllers, motion control, servo system, real-time embedded system, analog and digital circuits and devices;
6. Demonstrated ability to pursue tasks to completion
7. Broad exposure to HW/SW/Systems design, and technical depth in one or more engineering disciplines (Electrical, Mechanical, Software, etc)
8. Good English skills in writing and speaking