Senior Packaging Engineer for Medical Devices – NPI

Integra LifeSciences Corporation; Columbia (MD); Hybrid; USD 82,000 - 113,000; Full time

Job summary

Integra LifeSciences Corporation in Columbia, MD seeks a Senior Packaging Development Engineer I to lead package systems for sterile and non-sterile medical devices, supporting NPI, sustaining, and validation activities. You will design, test, and document packaging solutions in a fast-paced environment.

Reporting to Packaging Engineering, you will collaborate across R&D, Regulatory, Quality, and Operations, apply ISO 11607 and QSR principles, perform DOE and data analysis, and mentor junior

Qualifications

• Bachelor degree with 5+ years of experience or equivalent education and years of experience.
• Master degree with 3+ years of experience or equivalent education and years of experience.
• Doctoral degree with 0-2 years of experience or equivalent education and years of experience.
• Strong knowledge of Quality System Regulation (QSR), GMP, Design Controls, and basic Process Validation principles within the medical device industry, along with familiarity with FDA, ISO, ASTM, and ISTA requirements.
• Solid understanding of packaging materials, structures, components, and related conversion processes.
• Ability to read and interpret engineering drawings, with exposure to GD&T methodologies.
• Strong working knowledge and application of statistical analysis methods such as DOE, ANOVA, capability analysis, histograms, and normality testing.
• Strong technical writing and documentation skills, with the ability to independently develop clear, accurate protocols, reports, and specifications.
• Effective written and verbal communication skills, with the ability to influence cross-functional teams and communicate technical concepts, risks, and recommendations.

Responsibilities

• Lead the planning, design, development, and improvement of package systems for sterile and non-sterile medical devices.
• Ensure packaging meets requirements for functionality, safety, manufacturability, regulatory compliance, and sustainability.
• Collaborate with R&D, Quality, Regulatory, Labeling, Operations, and suppliers across product lifecycle.
• Lead or contribute to packaging initiatives focused on quality, cost, and standard work.
• Apply knowledge of packaging materials, processes, and test methods to support projects.
• Execute tasks with guidance and increase independence over time.
• Develop and evaluate packaging concepts and provide technical direction.
• Plan and execute DOE activities to support development and validation.
• Prepare technical reports and documentation summarizing test results and conclusions.

Skills

QSR/GMP

Design Controls

Process Validation

DOE/ANOVA

GD&T

Technical writing

Cross-functional

Education

Bachelor +5 yrs exp

Master +3 yrs exp

PhD +0-2 yrs exp

Tools

Microsoft Office

Statistical software

GD&T tools

Job description

Integra LifeSciences Corporation in Columbia, MD seeks a Senior Packaging Development Engineer I to lead package systems for sterile and non-sterile medical devices, supporting NPI, sustaining, and validation activities. You will design, test, and document packaging solutions in a fast-paced environment.

Reporting to Packaging Engineering, you will collaborate across R&D, Regulatory, Quality, and Operations, apply ISO 11607 and QSR principles, perform DOE and data analysis, and mentor junior