Process Engineer
We have a current opportunity for a Process Engineer on a contract basis. The position will be based in Cork. For further information about this position please apply.
Key Responsibilities:
Lead process development and validation for medical device manufacturing (IQ/OQ/PQ, PPAP, DOE).
Support New Product Introduction (NPI) from design transfer to full-scale production.
Develop and maintain process documentation including work instructions, PFMEAs, control plans, and process flow diagrams.
Identify and implement process improvements to enhance productivity, yield, and quality.
Interface with customers and suppliers on technical requirements and issue resolution.
Support regulatory and quality system compliance (ISO 13485, FDA QSR).
Provide technical support for equipment qualification and tooling validation.
Analyse process data to monitor performance and drive root cause analysis using Six Sigma or similar methodologies.
Participate in cross-functional project teams for CAPAs, audits, and continuous improvement initiatives.
Travel to customer or supplier sites (up to 30-40%) for technical support, training, or project coordination.