Tooling Engineer required for leading medical devices company based in Waterford City. The overall purpose of this role is the Tooling Engineer is responsible for developing and maintaining tooling specifications to meet specific component and project strategies.
Key Responsibilities and end results:
- 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.
- Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
Education and experience required:
- 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
- Strong knowledge of tool approval process, polymer materials & injection moulding processing
- Strong verbal and written communication skills
- Excellent organisational, systematic root cause problem solving skills
- Motivated, enthusiastic, self-directed & results driven with strong project management skills
- Ability to project manage across functional teams involving tooling vendors & suppliers
- Knowledge of Lean continuous improvement techniques including statistics & DOE