Sr. Process Engineer ( Invasive Medical Devices )

Job Responsibility：

• 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.

Qualification：

• 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.

Location：

Shanghai, China

Email to：

hr@wallabymedical.com