Senior Packaging Development Engineer I

Integra LifeSciences seeks a Senior Packaging Development Engineer to lead packaging design and development for sterile and non-sterile medical devices. The role involves executing NPI, sustaining, and continuous improvement projects while collaborating across R&D, Quality, Regulatory, and Operations functions.

Responsibilities

• Lead planning, design, development, and improvement of package systems for medical devices
• Execute Design of Experiments activities including setup, data collection, and documentation
• Collaborate with cross-functional teams to drive packaging design, validation, and implementation across product lifecycle
• Prepare and review technical reports, protocols, and documentation summarizing test results and engineering conclusions
• Provide guidance to junior engineers and lead small project teams or workstreams as assigned

Requirements

• Bachelor's degree with 5+ years packaging engineering experience, or equivalent education and experience
• Strong knowledge of QSR, GMP, Design Controls, and Process Validation in medical device industry
• Familiarity with FDA, ISO, ASTM, and ISTA requirements; ability to apply ISO 11607, ISO 13485, ISO 14971, and 21 CFR Part 820
• Solid understanding of packaging materials, structures, components, and conversion processes
• Strong working knowledge of statistical analysis methods including DOE, ANOVA, and capability analysis
• Proficiency with engineering drawings and GD&T methodologies
• Excellent technical writing and cross-functional communication skills