Job Description

Job Description

Responsibilities:

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• Lead packaging engineering activities for sterile and non-sterile medical devices throughout the product lifecycle.
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• Develop, execute, and maintain packaging design verification and validation activities.
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• Author and review packaging validation protocols and reports, including IQ, OQ, and PQ studies.
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• Develop and execute transportation/shipping validation protocols and testing.
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• Author and manage accelerated and real-time aging studies and associated documentation.
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• Ensure compliance with ISO 11607 and applicable medical device packaging standards and regulations.
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• Support design control activities, risk assessments, design changes, and product development projects.
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• Collaborate with contract manufacturers, packaging suppliers, material vendors, and testing laboratories to develop and qualify packaging solutions.
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• Evaluate packaging materials, specifications, and manufacturing processes to ensure product protection and regulatory compliance.
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• Troubleshoot packaging-related issues and implement corrective actions when necessary.
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• Contribute to the establishment and continuous improvement of packaging engineering processes, procedures, and documentation.
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• Partner with Quality, Regulatory Affairs, Operations, Supply Chain, and R&D teams to support product launches and ongoing commercial products.
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Qualifications:

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• Bachelor's degree in Packaging Engineering, Engineering, Science, or related technical field.
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• Minimum 6 years of medical device packaging engineering experience.
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• Direct experience supporting Class I, II, and/or III medical devices.
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• Experience with sterile and/or non-sterile packaging systems.
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• Strong background in packaging design verification and validation.
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• Hands-on experience developing and executing IQ, OQ, and PQ validation protocols.
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• Experience authoring shipping and transportation validation protocols and reports.
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• Experience developing and executing accelerated aging and shelf-life studies.
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• Working knowledge of ISO 11607 requirements.
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• Experience supporting design control processes and product development activities.
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• Strong technical writing and documentation skills.
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