Medical Device Packaging Engineer

7 days ago

Ballina, Mayo County, Ireland Independent Search Solutions Ltd Full time

Package: Full Time / Perm €75k – €85k+ Basic (Negotiable, dependent on experience) Annual Bonus (10%) Pension Health Insurance Paid Annual Leave Parking Canteen Relocation Package (€) Role: You'll lead Packaging Development across business units, driving excellence from concept through to commercialization.
You'll collaborate cross-functionally, mentor peers, and influence packaging decisions that ensure compliance, optimize performance, and enhance patient outcomes.
The Packaging Engineer will work on sterile medical device packaging activities for the business unit and associated manufacturing sites.
They will work as part of a team on new product development and commercialization, and changes to existing products.
This includes packaging and labelling system development, manufacturing, and performance to the point of end use.
They will also support business unit and departmental continuous improvement objectives.
Key Duties and Responsibilities: Lead cross-functional projects for new product development and commercialization, and changes to existing products Recommend new packaging materials, equipment, and suppliers Develop and validate sterile packaging and labelling systems and equipment Ensure compliance with and monitor changes to packaging regulations Write and coordinate technical documentation, including design assurance documents, protocols, reports, procedures, specifications, work instructions, and original data Develop and validate test methods Source and validate packaging test equipment Identify and support cost savings opportunities Represent the company at industry events (conferences, seminars, etc.)
Educate the organization on packaging best practices Experience: Third Level Qualification (Science or Engineering Discipline) 6 Years Previous Experience in Sterile Packaging System Development and Validation Skills Matrix: Automated and manual packaging forming, loading, sealing, closing, and labelling equipment selection, development, and validation Form-fill-seal and heat seal equipment Sterile barrier seal tooling development Flexible barrier material performance and selection Porous and non-porous material performance and selection Design of experiment and process validation Test methods for materials, integrity, physical properties, distribution simulation, and aging Fibre-based materials, including paperboard and corrugate Sterilization processes Labelling printers, application equipment, and vision systems Colour specification Human factors and usability engineering Advanced knowledge of ISO 11607, EU MDR, UDI, ASTM D10 and F02, IEC 62366, and FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices Experience with Qumas, SAP, CAPE, TOPS, JMP, Minitab, Microscan

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