
Posted 6 days ago
Process Engineer
AI Summary
Supports introduction, validation and continuous improvement of injection-moulded medical-device products and processes, including process qualification (IQ/OQ/PQ), machinery setup and root-cause investigations.
About this role
The role
As Process Engineer, you will support the introduction, validation and continuous improvement of products and processes. You will work across engineering, production, quality and maintenance activities, with a particular focus on injection moulding and medical-device manufacturing.
Key responsibilities
- Manage engineering projects, including new product and process introductions for medical-device applications.
- Lead or support process qualification activities, including IQ, OQ and PQ, and prepare the associated technical reports.
- Set up and validate new machinery, moulds, automation and auxiliary equipment.
- Deliver continuous-improvement projects focused on product quality, productivity, OEE, sustainability and energy efficiency.
- Maintain comprehensive engineering records in accordance with ISO 13485.
- Support root-cause analysis, NCR investigations and CAPA reporting.
- Use process-control technologies, including RJG eDART/CoPilot and Kistler systems to achive process capability and efficiency.
- Support maintenance activities involving moulds and manufacturing equipment
Qualifications & Experience
You should ideally hold a minimum of a bachelor’s degree in Mechanical Engineering, Polymer Engineering or a related engineering discipline. Experience in the following areas would be a distinct advantage:
- Injection moulding processes and tooling
- Medical-device process validation
- High-volume medical manufacturing
- Pneumatic, hydraulic and electrical principles
- PLCs, SolidWorks or other CAD systems
- ISO 13485 requirements
Skills
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