Our client, a global leader in medical devices is recruiting for an experienced Process Engineer for their Galway site.
- Previous new product development and/or manufacturing experience in medical / pharmaceutical industries a distinct advantage; in particular, strong knowledge and application of process and equipment validation techniques, PFMEA’s, and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes.
- Demonstrates strong technical expertise on process/product technologies to support selection, design, optimisation, validation and troubleshooting of, and can mentor engineers and technicians in problem resolution on, those technologies.
- Continuous improvement focus, demonstrating strong knowledge of Six Sigma methodologies and applies these tools in the characterization, optimization and troubleshooting of process equipment and technology performance
- Demonstrates strong knowledge and application of Lean methodologies, and process improvement tools in identification and elimination of "waste" process steps and development of efficient, cost effective equipment and processes.
- Liaises with Equipment Engineering or external equipment/tooling or material vendors in the selection, design & development of new (or upgrades to existing) equipment, tooling and materials.
- Leads the development and execution of experimentation and testing to enable characterisation, optimization and troubleshooting of key processes and equipment. and summarises, analyses and draws conclusions from test results leading to effective technical resolution.
- Co-ordinates 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.
- Completes or leads the writing and release of process validation documentation including FMEA's, Validation Plans, protocols and reports.
- Co-ordinates execution and documentation of validation builds, co-ordinates testing of validation units and the compilation, analysis and reporting of the validation results.
- Supervision of one or more Technicians, managing their technical development and facilitating their daily and project tasks as required.
- Demonstrates a primary commitment to patient safety and product quality.
- Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
- Understands and complies with all the regulations governing the quality systems.
- May lead a project team of small to moderate scope. Influence exerted at peer level and occasionally at first levels of management.
Travel to other sites / vendors as part of Technology development & transfer activities.
Education, Experience and Skills
- Honours Degree - HETAC Level 8; Minimum of 3 years post graduate experience.
- Working knowledge and application of business and technical concepts, procedures and practices. General knowledge of industry practices, techniques, and standards
- Develops solutions to a variety of problems of moderate scope and complexity where analysis of situations or data requires a review of identifiable factors. Exercises judgment to determine appropriate action.
- Works under general direction regarding the progress of projects and special assignments.
- Cultivates a wide range of internal business relationships and begins to develop an external network of resources to facilitate completion of tasks.
- Contributes to the completion of departmental projects and goals.
- Represents organization on specific projects.
For further information on this Engineer role in Galway please contact Anna McGowan on 0864667369/ firstname.lastname@example.org
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