Find and solve the problems of the process, technology and raw material on the production line.
Lead and participate in process design, process verification/validation for neurovascular intervention products; To establish the related plans, protocol, report and operation instructions.
Experienced in implementing IQ/OQ/PQ/PPQ.
Prepare operation instructions, drawings, and product’s quality requirement.
Troubleshoot for equipment and tooling, as well as some simple equipment maintenance.
Experienced in risk management and risk analysis during process design and process validation.
Lead process improvement, increase product’s yield rate , improve production efficiency, and reduce waste.
Lead nonconformity handling, operators training and manufacturing process improvement.
Design and maintain the tooling and equipment.
Cooperate with R&D, production and quality departments on product design and function test.
Experienced in mass production of medical devices.
Experienced in data analysis and statistics.
BS Degree in Engineering, and experienced workers in medical device field is preferred.
Experience in problems solving and data analyzing.
Knowledge of lean ,Six Sigma and root cause analysis.
Be capable of hand-on, innovation and learning, and good team worker.
Proficient in Microsoft Office, SolidWorks etc.
Familiar with FDA/CE regulatory requirements, understand GMP/ASTM/AAMI standards.
Proficient in English language is preferred.