An excellent opportunity for a Project/Process Engineer to join a market-leading medical device company based in Cork on an initial 12-month contract with great scope for extension.
The Packaging Engineer will plan and execute packaging activities to deliver the next generation semi-automated packaging line. The role involves leading cross functional teams to develop advanced manufacturing processes for the flawless execution of new product development projects. Collaborating with global packaging functions, the position will be responsible for ensuring optimum design for manufacturability in the introduction of new products.
Execution and project management responsibility for packaging aspects of the semi-automated line
Manage risk management and validation lifecycle for the packaging process change.
Execution of the validation requirements for new process (Change Controls, IQ/ OQ/PQ).
Conduct DOEs and Engineering Studies to ensure compliance.
Direct PFMEA studies and lead risk assessment effort for overall process.
Influence innovative qualification methodologies to apply appropriate statistical and validation techniques based on failure model and overall risk.
Design, develop and source tools, fixtures and special equipment for pack processes. Co-ordinate with internal and external partners.
Planning of key deliverables into action plans & provide timely and accurate reporting on project activities.
A minimum of a Bachelor’s degree in Engineering is required. A Masters or PhD is an advantage.
Demonstrated validation experience/ exposure
1-3 years experience in Medical Devices or regulated industry and exhibiting evidence of GDP and technical writing
Self-motivated, with focus on Quality, Delivery and Cost
Must be accustomed to fast-paced, high-pressure environment
For a confidential discussion and more information on the role, please contact Barry O'Brien.