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