Process Engineer

Date: 2020-05-06

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

Email to:

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