Senior Medical Device Packaging Engineer – NPI & Innovation

Integra-Lifesciences; Columbia (MD); On-site; USD 82,000 - 113,000; Full time

Benefits offered by this job

Pay transparency

Health benefits

Job summary

Integra LifeSciences in Columbia, MD is seeking a Packaging Engineer who will lead packaging design, testing, and validation for sterile and non-sterile medical devices. You will develop specifications and ensure compliance across the product lifecycle.

The role requires strong knowledge of QSR/GMP, Design Controls, and ISO 11607, with collaboration across R&D, Quality, Regulatory, and Operations to drive improvements and safe, compliant packaging solutions.

Qualifications

• Bachelor degree with 5+ years of experience in packaging engineering or equivalent.
• Familiarity with ISO 11607, ISO 13485, ISO 14971 and FDA 21 CFR Part 820.
• Strong knowledge of QSR, GMP, and Design Controls.
• Ability to read engineering drawings and GD&T.

Responsibilities

• Lead the design and improvement of package systems for sterile and non-sterile medical devices.
• Collaborate with R&D, Quality, Regulatory, Labeling, Operations across the product lifecycle.
• Plan and execute DOE activities to support packaging development and validation.
• Prepare and review technical reports and documentation summarizing test results.

Skills

QSR & GMP

Design Controls

Regulatory Standards

DOE & ANOVA

Statistical Analysis

Technical Writing

Cross-Functional

Education

Bachelor's degree in engineering

Master's degree in engineering

Doctoral degree

Tools

Microsoft Office

Excel

MS Project

Statistical Tools

Job description

Integra LifeSciences in Columbia, MD is seeking a Packaging Engineer who will lead packaging design, testing, and validation for sterile and non-sterile medical devices. You will develop specifications and ensure compliance across the product lifecycle.

The role requires strong knowledge of QSR/GMP, Design Controls, and ISO 11607, with collaboration across R&D, Quality, Regulatory, and Operations to drive improvements and safe, compliant packaging solutions.