Sr. Packaging Engineer

Job Title: Sr. Packaging EngineerLocation: North Haven, CTJob Summary:Seeking a Sr. Packaging Engineer with experience in medical device packaging validation to support manufacturing and quality activities. The role focuses on equipment qualification (IQ), process validation (OQ/PQ), DOE, statistical analysis, and regulated quality documentation while ensuring compliance with FDA and ISO standards.Key Responsibilities:Execute Equipment Qualification (IQ) and Process Validation (OQ/PQ).Support packaging validation activities across manufacturing lines.Perform statistical analysis and DOE for process improvements.Develop SOPs, manage change controls, and maintain validation documentation.Collaborate with Quality, Manufacturing, and Engineering teams.Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR requirements.Required Skills:Experience with IQ, OQ, PQ, and Process Validation.Knowledge of DOE and statistical data analysis.Experience with regulated quality records and validation documentation.Medical Device industry experience.Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR.Education:Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical field.