Packaging Engineer

We are seeking a Packaging Engineer with a strong mechanical engineering background to support the design, development, validation, and continuous improvement of medical device packaging systems. The ideal candidate will have experience in packaging materials, sterile barrier systems, transportation testing, design verification/validation, and regulatory compliance within a regulated medical device environment.Key Responsibilities Design and develop primary, secondary, and tertiary packaging solutions for medical devices and combination products. Collaborate with R&D, Manufacturing, Quality, Supplier Quality, and Regulatory Affairs teams during NPD/NPI activities. Develop packaging concepts using CAD tools such as SolidWorks or AutoCAD. Perform packaging feasibility studies, tolerance analysis, and mechanical assessments for product protection and usability. Support sterile barrier system development and packaging validations per ISO 11607 requirements. Execute and document IQ/OQ/PQ protocols for packaging equipment and processes. Conduct transportation and distribution testing including vibration, compression, drop, and environmental testing per ASTM and ISTA standards. Evaluate packaging materials including thermoforms, trays, Tyvek pouches, cartons, foams, corrugates, labels, and cold-chain packaging systems. Perform root cause analysis and implement CAPA activities related to packaging failures or nonconformances. Coordinate with suppliers and contract manufacturers for packaging material qualification and change control. Support risk management activities in accordance with ISO 14971. Generate and maintain packaging specifications, BOMs, drawings, SOPs, protocols, and technical reports. Ensure compliance with FDA, ISO 13485, GMP, and company quality system requirements. Participate in continuous improvement initiatives focused on cost reduction, sustainability, manufacturability, and process optimization.