The Packaging and Labelling Engineer will provide technical leadership to all aspects of packaging design, labelling and configurations in an award winning high growth medical device company.
- Lead the design and co-ordination of packaging and labelling activities for New Product Development, legacy packaging, and labelling update projects. This will include product packaging design, product labels, DFU’s (Directions for Use) and labelling specification generation.
- Design and Build a Labelling and Packaging excellence program to standardize design approach and remediate existing packaging.
- Work with Lean Engineering to review opportunities for cost reduction within the Packaging process.
- Knowledge of Barcoding systems and oversee compliance to labelling standards (examples GS1 and UDI).
- Interface with the Quality Assurance and Regulatory departments to provide packaging and labelling input to product submissions.
- Generating design assurance documentation for the project (label specifications, BoM’s, DMR’s, PRTM, Risk documentation) using a high degree of initiative to seek out information for documents.
- Oversee packaging testing (ISTA 2) as required building Quality into all aspects of work by maintaining compliance to quality requirements.
- Co-ordination of activities, both internal and external, to meet Product registration requirements for new global regions.
- Perform other assigned tasks as directed by Supervisor or Head of Function.
- Minimum 5 years’ experience in the Medical Device Industry and / or other regulated industry.
- Level 8 degree in an Engineering or Technical Discipline.
- Excellent understanding of Packaging and Labelling standards.
- Experience in Packaging characterization, Validation, and statistical methods.
- Excellent interpersonal skills with an ability to coordinate project activity with Commercial, Supply Chain, Regularity Affairs, Production and Design functions.
- Very strong organizational, Project Management and communication skills.
- Meticulous attention to detail with a methodical and analytical approach to problem solving.
- Flexibility to travel to vendor sites to support service and project activities.
- Must be able to work in a dynamic environment with little supervision or daily direction.
- Typical office environment with work also performed in Manufacturing areas in addition to supplier locations.
For further information on this Packaging & Labelling Engineer role in Galway please contact Amanda Reynolds on 0860468858/ firstname.lastname@example.org
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