- 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, MS Degree 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, SolidWork etc.
- Familiar with FDA/CE regulatory requirements, understand GMP/ASTM/AAMI standards.
- Proficient in English language.
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