Responsible for developing and maintaining tooling specifications to meet specific component and project strategies.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Project manage optimisation, maintenance & overhaul projects on existing tool portfolio (prototype single cavity & production multi-cavity tools)
- Apply systematic root cause problem solving involving all stakeholders (including key support department team members & tooling/equipment vendors) to meet customer delivery & product quality objectives in the most cost-effective manner
- Lead the use of lean tools to drive continuous improvement & process reliability on tools
- Work with Device Development Services (DDS) & New programme personnel to support the introduction of new tools to site for new products to ensure high levels of process reliability post PQ.
- Lead the injection moulding tooling technical function for both internal project teams and client teams and manage new injection mould tool introduction to the Operations team.
- Development and implementation of multi-cavity Tooling strategies for complex and/or large tooling builds with optimal cavitation and cycle times to meet the needs of a robust manufacturing process and quality requirements
- Participate and lead product development or project meetings, including performance and presentation of the DFM/DFA recommendations. Participate in Risk Assessment/Analysis (dFMEA, pFMEA).
- Participation and development of measurement inspection techniques, fixtures and test methods.
- Manage mold flow requirements and translate data into final conclusions for use in tooling considerations.
- Ensure all engineering changes are managed through the relevant cGMP procedures including documentation, equipment manuals, QCBD records & CAD drawing controls
- Create a high performing flexible tooling team which achieves excellent results.
- Provide direction to tooling personnel as appropriate reviewing tool downtime & preventative maintenance data , tool running status, escalations & corrective action to ensure targets are achieved
- Ensures that there is regular communication & coordinated planning of all new & existing tool projects using visual communications boards within tooling
- Implementation of company policies, adherence to all Corporate EHS and cGMP policies
- Ensure ongoing compliance with GMP in all practices, recording of events and processes.
- Ensure compliance with all learnings from all GMP training events.
- Mechanical Engineering degree, qualified Toolmaker or relevant experience as a Tooling Engineer
- Excellent knowledge of multi cavity injection mould tools and hot runner systems.
- 5+ years tool development experience, preferably in medical devices
- Strong tooling and product design skills, with a working knowledge of 2D/3D CAD
- Knowledge of resin materials and processing techniques for tool building and polymer processing
- Experience in rapid prototyping techniques and their application
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