Overview
Skills
Job Details
About the Role
We're seeking a Packaging Engineer to design, develop, and validate packaging solutions for cardiovascular medical devices. You'll ensure packaging is safe, sterile, cost-effective, and compliant with global regulations while supporting new product launches and process improvements.
Key Responsibilities
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Design sterile and non-sterile packaging (trays, pouches, cartons, shipping containers).
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Perform packaging verification, validation, and sterilization compatibility testing.
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Collaborate with R&D, Manufacturing, Quality, and Regulatory teams.
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Ensure compliance with ISO 11607, FDA, and international standards.
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Work with suppliers to qualify packaging materials and components.
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Drive cost, performance, and sustainability improvements.
Qualifications
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Bachelor's degree in Packaging, Mechanical, or related engineering field.
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5+ years of packaging experience in medical devices or life sciences.
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Knowledge of ISO 11607, FDA 21 CFR Part 820, ASTM/ISTA standards.
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Experience in packaging validation and sterilization methods (EtO, e-beam).
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Strong communication, teamwork, and problem-solving skills.
Preferred
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Cardiovascular device experience.
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Knowledge of usability studies, Lean Six Sigma, or process improvement.