Job Description
General Description:
To maximize the performance of manufacturing processes within GMIL through providing high impact technical/operational support, and by developing processes to the highest possible standards. To co-ordinate and complete complex projects against challenging timelines. To apply a methodical approach to problem-solving and problem prevention.
Key Roles and Responsibilities:
- Implement appropriate process controls for manufacturing processes for robust and repeatable commercial product manufacturing.
- Maximise manufacturing process performance through implementation of continuous improvement methodology.
- Apply a scientific approach to problem solving, combining analytical and experimental skills to maximise overall equipment effectiveness and efficiency.
- Ensure that all Engineering work and designs are carried out to appropriate GMP, QA/Regulatory Authority standards and Environmental Health and Safety standards.
- Manage projects using PM principles with effective timeline management and task coordination and execution.
- Support the development of new processes in conjunction with Process/Manufacturing/Automation Engineering ensuring that new processes are stable and capable.
- Provide technical support to new product/technology introductions and ensure change is effectively managed.
- Ensure that non-conforming products and processes are evaluated and corrected on assigned projects in accordance with process controls and procedures.
- Successfully complete validations and process improvements using statistical tools and six sigma techniques.
- Support the development of in-house Subject Matter Experts (SME) across the range of core technologies.
- Support process/equipment/H&S risk assessment and analysis of risk to product or user.
Knowledge and Educational Requirements:
- Honours Degree in Mechanical/Manufacturing Engineering or equivalent discipline with relevant experience.
- Catheter manufacturing experience is desired.
- A minimum of 3 years of professional experience in a responsible Manufacturing Engineering/Process Development role within the Medical Device/Healthcare.
- Proven and successful implementation of continuous improvement initiatives is essential.
- A complete understanding of how to measure production line performance is required.
Job Type: Full-time
Work Location: In person
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