Looking for a Process Engineer with Medical Device experience for a new role based in Co. Clare. The role will be in a new cleanroom with a strong focus on validations and process improvement.
- Provide strong technical support on process/product technologies to support production.
- Set up, maintenance of and troubleshooting of production machines. Root cause and problem solve production issues for Injection Moulding Machines.
- Own and complete CAPA’s and NC’s related to production issues. Continuous improvement focus, demonstrating strong knowledge of Six Sigma methodologies
- Identify and eliminate "waste" process steps and development of efficient, cost effective equipment and processes.
- Liaise with Engineering team or external equipment/tooling or material vendors in the selection, design & development of new (or upgrades to existing) equipment, tooling and materials.
- Lead the development and execution of experimentation and testing to enable characterisation, optimization and troubleshooting of key processes and equipment.
- Co-ordinate the introduction of new processes, equipment and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions.
- Complete or lead the writing and release of process validation documentation including FMEA's, Validation Plans, protocols and reports.
- Co-ordinate execution and documentation of validation builds, co-ordinates testing of validation units and the compilation, analysis and reporting of the validation results.
- A degree in a relevant engineering subject or diploma with relevant additional medical device experience
- Minimum of 3 years’ experience in a manufacturing environment Experience and knowledge of injection moulding machines, process set up and optimization.
- Experience in Blow Moulding would be a distinct advantage.
- Good understanding of all the regulations governing the quality systems.
- Technical Writing Experience would be desirable.
If you are interested in this Process Engineer role, please send your resume to email@example.com or call me on 091 455 300 for more information.
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