Location: Galway, Ireland
Experience: 3–5 Years
Role Summary
We are seeking an experienced Packaging Engineer to support medical device packaging design, development, testing, validation, and
design control activities. The role will support new product development, product transfers, packaging design changes, and
regulatory submissions within multidisciplinary project teams.
Key Responsibilities
• Design and develop medical device packaging solutions.
• Lead packaging activities for new product development, product transfers, and design changes.
• Develop prototype packaging models to evaluate design concepts.
• Plan, execute, and own packaging testing and validation activities.
• Develop test protocols, validation protocols, reports, and technical documentation.
• Lead packaging evaluations with internal and external stakeholders.
• Lead packaging-related Design Control documentation.
• Support documentation required for regulatory submissions.
• Manage technically complex packaging projects, milestones, risks, and timelines.
• Perform engineering evaluations involving drawings, dimensions, tolerance stack-ups, and specifications.
• Analyze validation and test data using statistical tools and draw appropriate conclusions.
• Identify technical risks and develop appropriate packaging solutions.
• Collaborate with R&D, Quality, Regulatory, Manufacturing, Operations, Supply Chain, and suppliers.
Technical Skills
• Medical device packaging design and development.
• Packaging verification and validation.
• Knowledge of FDA and EU MDR packaging requirements.
• Knowledge of applicable medical packaging standards and test methods.
• Medical packaging materials and manufacturing processes.
• Design Controls and regulatory documentation.
• Engineering drawings, GD&T, dimensional tolerances, and tolerance stack-ups.
• Statistical analysis of packaging test and validation data.
• Microsoft Office, Excel, Visio, and project-management tools.
Candidate Profile
• Strong technical writing and documentation skills.
• Effective communication and presentation skills.
• Strong analytical and problem-solving capabilities.
• Ability to lead cross-functional technical discussions.
• Ability to evaluate multiple solutions and identify potential risks.
• Strong project planning and execution skills.
• Ability to work effectively across Engineering, Quality, Regulatory, and Manufacturing teams.
Education & Experience
• Bachelor's degree in Packaging Engineering or a related Engineering discipline.
• 3–5 years of relevant packaging engineering experience, preferably within the medical device or regulated healthcare industry.
• Hands-on experience in packaging development, testing, validation, design changes, and/or product transfers preferred.
- Work Location: Ireland