Job Description

Job Description

We have an exciting new opportunity for a Packaging Engineer near Indianapolis, IN. We are looking for someone with experience in medical device packaging, to design and develop innovative packaging solutions for new and modified products. In this role, you will support product design, verification testing, regulatory compliance, process validation, and manufacturing line establishment. You will lead packaging activities with a cross-functional team, including Product Management, Regulatory Affairs, Operations, Quality Assurance, Clinical Affairs, and other Engineering personnel.

• Apply packaging design principles from the Medical Device/Pharma field to develop packaging designs that meet company, customer, and industry standards.
• Collaborate with suppliers to spec and acquire packaging materials.
• Coordinate distribution simulation and packaging testing.
• Develop and maintain department standards in packaging.
• Lead multiple projects to successful completion with tight timelines and critical deliverables.
• Ensure compliance of equipment and packaging designs with company quality system.
• Coordinate or perform verification and validation testing of packaging designs and manufacturing methods.
• Write and maintain appropriate documentation per the company quality system.
• Evaluate issues with existing packaging and implement corrective actions

• Master of Science in Packaging Science or a closely related field, or a Bachelor's degree in Mechanical Engineering, Packaging Science, or a closely related field with 5 years of relevant experience.
• Experience with medical packaging materials (Tyvek, PE/PET films, PETG trays, etc.).
• Knowledge of environmental and regulatory requirements and standards related to medical packaging design and testing (e.g., ASTM F1886, F88, F2096, D4169, and ISO 11607).

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