Manufacturing Engineer

Currently seeking a Sr. Manufacturing Engineer to join a Medical Device client to support the Qualification of a Cleaning & Sterilisation Process onto their site.

This is an ASAP start, full time and long-term hourly rate contract, primarily on site in East Cork.

Ideal candidates possess a strong experience in Medical Device Engineering roles. Validation expertise is essential (IQ/OQ, EQ, PQ, MSA), with a preference for candidates with experience with Cleaning & Sterilisation.

Responsibilities:

• Responsible for assisting process improvement and problem-solving manufacturing issues using Six-Sigma tools.
• Providing technical leadership on all product and process issues.
• Line performance monitoring, and the compilation and execution of structured event plans to remediate systemic issues that drive sub-optimal performance.
• Development and implementation of appropriate supporting documentation, SOPs and process work instructions compliant with current Good Manufacturing Practices (GMP)
• Leading technical improvements under the business's Continuous Improvement Program (CIP).
• Transferring and implementing processes, either from development, or from another manufacturing facility.
• Provide engineering support for new Product and new process introduction, ensuring that all activities are completed and documented according to New product Development Process.
• Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation.
• Conduct Gauge R&R studies for products and new processes.
• Responsibility for projects (value stream and cross functional) as assigned by the company, including the scoping, approval, budgeting, specification, execution, qualification and operational handover as appropriate.
• Observing the Quality Management Systems requirements on site at all times
• Continuous monitoring and reporting of variables that feed into the business performance metrics, and pro-active identification and resolution of issues around any deficits in same.
• Adherence to, and enforcement of all Environment Health and Safety (EHS) requirements on site
• Elimination and/or management of material risks on the production floor in co-operation with Supplier Quality engineers