Senior Packaging Development Engineer I

Integra LifeSciences seeks a Senior Packaging Development Engineer to lead packaging design and development for medical devices across multiple facility locations. The role involves specifications, testing, validation, and cross-functional collaboration to support new product introductions and continuous improvement initiatives.

Responsibilities

• Lead design, development, and improvement of sterile and non-sterile medical device packaging systems
• Define design requirements and performance criteria through cross-functional collaboration with R&D, Quality, Regulatory, and Operations
• Plan and execute Design of Experiments activities, data collection, and statistical analysis to support validation efforts
• Develop technical reports and documentation summarizing test results, DOE outcomes, and engineering conclusions
• Mentor junior engineers and lead small project teams on packaging development initiatives

Requirements

• Bachelor's degree with 5+ years packaging engineering experience, or Master's with 3+ years, or PhD with 0-2 years
• Strong knowledge of QSR, GMP, Design Controls, and Process Validation in medical device industry
• Proficiency with FDA, ISO, ASTM, and ISTA standards including ISO 11607, ISO 13485, and ISO 14971
• Solid understanding of packaging materials, structures, components, and conversion processes
• Demonstrated ability to design and execute DOE, statistical analysis, and capability studies
• Strong technical writing skills and ability to develop protocols, reports, and specifications
• Proficiency with Microsoft Office and statistical analysis tools