Lead Packaging Engineer

Hollister Incorporated; Ballina; On-site; EUR 90,000 - 120,000; Full time

Job summary

Hollister Incorporated in Ballina, Ireland seeks a Senior Packaging Engineer to lead medical device packaging activities for Ostomy and Continence Care products. You will serve as a technical SME for new product development, changes and commercialization of packaging and labeling systems from development through end use.

The role includes establishing project schedules, validating sterile and non-sterile packaging, ensuring regulatory compliance, and mentoring peers within the department.

Qualifications

• 8+ years of overall industry experience with a Bachelors degree
• 6+ years with Master’s degree
• Experience in medical device packaging development and commercialization
• CAD and concept prototyping
• Medical device sterile/nonsterile packaging system development and/or validation
• Technical writing and cost optimization
• Design of experiments and process validation
• Test methods for materials, integrity, physical properties, distribution simulation, and aging
• Rigid and flexible sterile barriers
• Fiber-based materials including paperboard and corrugate
• Porous and non-porous materials
• Sterilization processes
• Form-fill-seal and heat seal equipment
• Manual and automated packaging processes
• Advanced statistical analysis
• Printed color specification and measurement

Responsibilities

• Lead cross-functional projects for new product development and commercialization, and changes to new and existing products.
• Apply advanced knowledge, independently, on concepts, principles, and technical capabilities for projects of large scope and complexity.
• Establish and manage packaging project schedules.
• Develop and validate sterile and non-sterile packaging and labeling systems and equipment.
• Establish and qualify new packaging materials, equipment and suppliers.
• Ensure compliance with and monitor and influence changes to packaging regulations.
• Identify and lead cost savings initiatives.
• Write and coordinate technical documentation including protocols, reports, procedures, specifications, work instructions and original data.
• Coach peers when needed for the technical requirements.
• Develop and validate test methods with statistical analysis.
• Source and validate laboratory equipment for new product commercialization.
• Represent Hollister at industry events (conferences, seminars, etc.)
• Mentor peers within department.

Skills

Packaging development

Statistical analysis

Technical writing

Design of experiments

Cross-functional leadership

Cost reduction

Education

Bachelor of Science in Packaging

Advanced Degree desirable

Tools

ArtiosCAD

SolidWorks

CAP E

TOPS

JMP

Minitab

Qumas

SAP

Veeva

Job description

We Make Life More Rewarding and Dignified

Location

Ballina

Department

Research & Development

Summary

Global Packaging serves Hollister and its product end users by providing packaging engineering expertise to develop optimized and compliant packaging systems. We help our organization drive cost competitiveness, improve operating efficiencies and effectiveness, and sustain performance in quality, service, and product commercialization. The Senior Packaging Engineer will contribute to Hollister's growth, profitability, and continuity by leading medical device packaging activities for the Ostomy and Continence Care business units and associated manufacturing sites. They will serve as technical subject matter experts for new product development and commercialization, and changes to existing products. This includes packaging and labeling system development, manufacturing, and performance to the point of end use. They will also support the business unit and departmental continuous improvement objectives and coaches' best practices for CFT.

Responsibilities

• Lead and coach cross-functional projects for new product development and commercialization, and changes to new and existing products.
• Apply advanced knowledge, independently, on concepts, principles, and technical capabilities for projects of large scope and complexity.
• Establish and manage packaging project schedules.
• Develop and validate sterile and non-sterile packaging and labeling systems and equipment.
• Establish and qualify new packaging materials, equipment and suppliers.
• Ensure compliance with and monitor and influence changes to packaging regulations.
• Identify and lead cost savings initiatives.
• Write and coordinate technical documentation including protocols, reports, procedures, specifications, work instructions and original data.
• Coach peers when needed for the technical requirements.
• Develop and validate test methods with statistical analysis.
• Source and validate laboratory equipment for new product commercialization.
• Represent Hollister at industry events (conferences, seminars, etc.)
• Mentor peers within department.

Essential Functions Of The Role

• Conduct sterile packaging material testing, travel to plants/suppliers for validation/SAT and distribution simulations in laboratory environment and statistical analysis.

Work Experience Requirements

• Number of Overall Industry Experience: 8+ Years with a Bachelors Degree, 6+ Years with Master's Degree
• Experience to include:
  • Medical device or FMCG packaging development and commercialisation
  • CAD and concept prototyping
  • Medical device sterile/nonsterile packaging system development and / or validation
  • Technical writing
  • Optimization and cost savings
  • Design of experiment and process validation
  • Test methods for materials, integrity, physical properties, distribution simulation, and aging
  • Rigid and flexible sterile barriers
  • Fiber-based materials, including paperboard and corrugate
  • Porous and non-porous materials
  • Sterilization processes
  • Form-fill-seal and heat seal equipment
  • Manual and automated packaging processes
  • Advance Statistical analysis
  • Printed color specification and measurement

Educational Requirements

• Bachelor of Science in Packaging or relevant Bachelor of Engineering.
• Advanced Degree is desirable

Specialised Skills/Technical Knowledge

• Proficient in ISO 11607, MDR, UDI, GS1, ASTM D10 and F02, ISTA
• Proficient with Qumas, SAP, ArtiosCAD, Solidworks, CAPE, TOPS, JMP, Minitab, Microscan, PXSmartPrint, Veeva,
• Advance knowledge of EU MDR, PPWR, UDI, IEC 62366, and FDA Guidance on Applying Human Factors
• Knowledge of Usability Engineering to Medical Devices
• Ability to influence packaging decisions as required

About Hollister Incorporated

Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services and as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

EOE Statement

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.