Our client a medical device Company based in Galway City are currently looking for a Graduate R&D Packaging Engineer based in Galway on a 24 month defined term contract initially.
Assists in the development of packaging labelling for Medical Device products. Compiles, analyses and reports test and research data to establish performance standards for newly designed or legacy product packages, labelling or materials
- This individual will be responsible for the design and co-ordination of packaging & labelling activities for New Product Development (NPD) and Sustaining Engineering (SE) of legacy products, packaging and labelling. This will include product package design, product labels, DFU’s (Direction for Use) and packaging specifications. Some knowledge of EU MDR requirements would be an advantage.
- Translates symbol requirements for ISO 15223: 2016 for customers requiring labelling for medical devices
- Creation, change and control of all labelling and packaging components to support R&D in the plant.
- Translates requirements for ISO 11607-1 & 2 :2006 for customers requiring packaging for terminally sterilized products to internal product development teams and packaging personnel supporting these operations.
- Liaise with vendors on specifications for package and label components
- Communicate to Teams and Management on the progress of labelling and packaging projects
- Liaise with Sister divisions to ensure a consistent approach to labelling and packaging
- Communicate with various departments on packaging related projects
- Build Quality into all aspects of work by maintaining compliance to all quality requirements
- Liaise with various translation companies for the translation of text used in all labelling and packaging components.
- Good understanding of Packaging & Labelling Design Element requirements within a regulated industry
- Understanding of EU MDR requirements
- Bachelors (Hetac Level 8) in relevant discipline
- 2-5 years' experience in a Medical Device or other regulated industry
- Familiar with ISO 13485, FDA Design Control, CAPA, SCAR and audit procedures
- Working knowledge of ISO 11607, ASTM D6198 and ISO 15223
- Ability to work with minimal supervision
- Excellent interpersonal and communications skills
All Applicants must have authorisation to work in the EU
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