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Job Description
Manufacturing Engineer responsible for implementing process controls, maximising manufacturing performance, and ensuring compliance with GMP, QA/Regulatory Authority standards and Environmental Health and Safety standards.
Key Responsibilities:
- Implement process controls for robust and repeatable commercial product manufacturing.
- Maximise manufacturing process performance through continuous improvement methodology.
- Apply scientific approach to problem solving, combining analytical and experimental skills.
- Ensure all Engineering work and designs meet GMP, QA/Regulatory Authority standards and Environmental Health and Safety standards.
- Manage projects using PM principles with effective timeline management and task coordination.
- Support development of new processes in conjunction with Process/Manufacturing/Automation Engineering.
- Provide technical support to new product/ technology introductions and ensure change is effectively managed.
- Evaluate and correct non-conforming products and processes in accordance with process controls and procedures.
- Complete validations and process improvements using statistical tools and six sigma techniques.
- Support development of in-house Subject Matter Experts (SME) across core technologies.
- Support process/ equipment/ H&S risk assessment and analysis of risk to product or user.
Qualifications and Requirements:
- Honours Degree in Mechanical / Manufacturing Engineering or equivalent discipline.
- Relevant experience in Manufacturing Engineering/ Process Development role within Medical Device/Healthcare industry.
- Catheter manufacturing experience desired.
- Proven and successful implementation of continuous improvement initiatives.
- Complete understanding of how to measure production line performance.