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. Key Responsibilities 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. Technical Must-Haves 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 Preferred Qualifications 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. #J-18808-Ljbffr
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