Sr. Process Engineer ( Invasive Medical Devices )

Date:2022-04-06

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

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