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. Purpose Statement
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
For further information on this Graduate R&D Packaging Engineer role in Galway please contact Edel Kelly on 087-4108620 / email@example.com Check out all our open jobs on our HERO Recruitment website – www.hero.ie
Please Note: HERO Recruitment will not forward your details to any company without your prior approval
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