Packaging Engineer

The Packaging Engineer will support the design, development, testing, validation, and qualification of packaging systems for sterile and non-sterile medical devices. The role involves working with cross-functional teams (R&D, Quality, Manufacturing, Regulatory, Supply Chain) to ensure packaging meets quality, regulatory, and customer requirements.

• Develop, test, and validate medical device packaging systems.
• Support packaging design control activities and maintain packaging specifications/documentation.
• Create and update technical documents, protocols, reports, work instructions, and change controls.
• Perform packaging verification and validation testing, data collection, and analysis.
• Support packaging projects from concept through commercialization.
• Assist with problem-solving, root cause analysis, and continuous improvement initiatives.
• Collaborate with Quality, Manufacturing, Regulatory, and R&D teams.
• Ensure compliance with medical device packaging standards and quality system requirements.

• Medical Device Packaging experience
• Knowledge of Medical Device Design Controls
• ISO 11607 experience
• Knowledge of Class II and/or Class III Medical Device regulations
• Protocol Writing
• Scientific / Technical Writing
• Packaging Specifications and Documentation
• Sterile Barrier Systems / Medical Device Packaging

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or related field.
• 1–3 years of Packaging Engineering experience.
• Experience in Medical Devices, Pharmaceuticals, or another regulated industry.