Job ID :
Singapore - Marsiling
- Provide sustaining engineering support to develop and improve manufacturing process
- Provide engineering support to improve product manufacturing first pass yield
- Support RnD and production to develop manufacturing test tooling and fixtures
- Perform engineering evaluation to support alternate component or part qualification to mitigate component or part end of life (EOL) concern
- Perform manufacturing process validation (IQ/OQ/PQ) for new manufacturing line and test fixture setup.
- Participate in production daily meeting to resolve instrument assembly and testing failures.
- Maintain and ensure systems and procedures are in compliance with ISO, Regulatory and housekeeping
- - Plan and execute activities with other department to ensure common goals are met.
- Bachelor of Science in Mechanical Engineering with minimum 3 years of experience in a BioTech or Medical Instrument manufacturing environment.
- Good knowledge of GMP and ISO13485 requirement
- Ability to perform failure investigation independently
- Good analytical skills and ability communicate effectively with all band level
- Understanding of ISO9001, ISO13485, ISO14971 and 21CFR Part 820 requirements.
- Laview programming experience will be an added advantage