Senior Packaging Engineer – Medical Device Packaging Validation

Job Description

We are seeking an experienced Senior Packaging Engineer to support and improve packaging operations in medical device manufacturing. The role involves leading packaging process development, equipment qualification, and validation activities, including IQ/OQ/PQ. The engineer will collaborate with Manufacturing, Quality, Regulatory, Operations, and Engineering teams to resolve production issues, implement continuous improvement initiatives, and ensure compliance with FDA and quality system requirements. Responsibilities include root cause investigations, CAPA development, technical documentation, and packaging process validation. The ideal candidate will have strong problem-solving, project leadership, and communication skills, along with experience driving operational excellence through Lean Manufacturing and Six Sigma methodologies.

Key Skills

• Packaging process development and optimization
• Packaging equipment qualification and validation (IQ/OQ/PQ)
• Medical device packaging operations
• Root cause analysis and CAPA
• FDA and quality system compliance
• Manufacturing process improvement
• Lean Manufacturing and Six Sigma methodologies
• Technical documentation and validation reporting
• Cross-functional collaboration and project leadership

Required Qualifications

• Bachelor's degree in Packaging Engineering, Packaging Science, Mechanical Engineering, Chemical Engineering, or a related engineering discipline.
• 7+ years of Packaging Engineering experience, or an equivalent advanced degree with relevant experience.
• Knowledge of packaging validation, manufacturing processes, quality systems, and regulatory requirements.