This is a great opportunity to work with a major global player in medical technology. The organisation is employee owned and offers excellent career development opportunities.
This key role for the business will act as SME, providing engineering expertise to develop packaging and labelling systems. The role is based locally but reports to a Senior Manager for Global Packaging in the US. Your role focuses on assisting the organisation drive cost competitiveness whilst looking at improvements in manufacturing and product.
Apply working knowledge, under general guidance, on concepts, principles, and technical capabilities for projects of moderate scope and complexity.
Support cross-functional projects for new product commercialization and changes to existing products.
Establish and manage packaging project schedules.
Recommend and qualify new packaging materials, equipment, and suppliers.
Develop and validate sterile and non-sterile packaging and labelling systems and equipment.
Ensure compliance with and monitor changes to packaging regulations and standards.
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 Hollister at industry events (conferences, seminars, etc.)
Educate the organization on packaging best practices.
Conduct packaging validations on the manufacturing floor.
Work Experience Requirements
Number of Overall Years Necessary: 3-6
Sterile medical device packaging system development and validation
Automated and manual packaging forming, loading, sealing, closing, and labeling equipment selection, development, and validation
Form-fill-seal and heat seal equipment/tooling
Flexible (porous and non-porous) and rigid sterile barrier material performance and selection
Fiber-based materials, including paperboard and corrugate
Design of experiment and process validation
Test methods for materials, integrity, physical properties, distribution simulation, and aging
Labeling printers, application equipment, and vision systems
Printed color specification
Optimization and cost savings
Bachelor of Science in Packaging or other relevant discipline. Advanced degree desirable.
Specialised Skills/Technical Knowledge:
Moderate knowledge of ASTM D10 and F02 and ISO 11607
Basic knowledge of EU MDR, UDI, IEC 62366, and FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices
Experience with Qumas, SAP, CAPE, TOPS, JMP, Minitab, Microscan or similar
This role is very well remunerated with competitive basic salary, company pension plan, full private family healthcare, annual bonus etc.
Further details on the role are available upon request.
For a confidential discussion and more information on the role, please contact Davin Ferguson