Senior Packaging Development Engineer

2 weeks ago

Galway, Galway, Ireland beBeePackaging Full time €75,000 - €85,000

Job Title:

Packaging Solutions Specialist

We are seeking an experienced Packaging Solutions Specialist to lead cross-functional projects for new product development and commercialization, and changes to existing products.

About the Role:

The successful candidate will work on sterile medical device packaging activities for our business unit and associated manufacturing sites. They will collaborate cross-functionally, mentor peers, and influence packaging decisions that ensure compliance, optimize performance, and enhance patient outcomes.

Main 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 us at industry events (conferences, seminars, etc.)
  • Educate the organization on packaging best practices

Requirements:

  • Bachelor's Degree in a Science or Engineering Discipline
  • 6 Years Previous Experience in Sterile Packaging System Development and Validation

Skill 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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