Senior Staff Packaging Engineer

Job Description Responsibilities: Lead packaging engineering activities for sterile and non-sterile medical devices throughout the product lifecycle. Develop, execute, and maintain packaging design verification and validation activities. Author and review packaging validation protocols and reports, including IQ, OQ, and PQ studies. Develop and execute transportation/shipping validation protocols and testing. Author and manage accelerated and real-time aging studies and associated documentation. Ensure compliance with ISO 11607 and applicable medical device packaging standards and regulations. Support design control activities, risk assessments, design changes, and product development projects. Collaborate with contract manufacturers, packaging suppliers, material vendors, and testing laboratories to develop and qualify packaging solutions. Evaluate packaging materials, specifications, and manufacturing processes to ensure product protection and regulatory compliance. Troubleshoot packaging-related issues and implement corrective actions when necessary. Contribute to the establishment and continuous improvement of packaging engineering processes, procedures, and documentation. Partner with Quality, Regulatory Affairs, Operations, Supply Chain, and R&D teams to support product launches and ongoing commercial products. Qualifications: Bachelor's degree in Packaging Engineering, Engineering, Science, or related technical field. Minimum 6 years of medical device packaging engineering experience. Direct experience supporting Class I, II, and/or III medical devices. Experience with sterile and/or non-sterile packaging systems. Strong background in packaging design verification and validation. Hands-on experience developing and executing IQ, OQ, and PQ validation protocols. Experience authoring shipping and transportation validation protocols and reports. Experience developing and executing accelerated aging and shelf-life studies. Working knowledge of ISO 11607 requirements. Experience supporting design control processes and product development activities. Strong technical writing and documentation skills.