Senior Medical Device Packaging Engineer

INTEGRA LIFESCIENCES CORP; Columbia (MD); On-site; USD 81,650 - 112,700; Full time

Benefits offered by this job

Medical

Dental

Vision

Life Insurance

Short-Term Disability

Long-Term Disability

Business Accident Insurance

Group Legal Insurance

Savings Plan (401(k))

Job summary

Integra LifeSciences is seeking a packaging engineer to lead the design and improvement of packaging systems for sterile and non-sterile medical devices. You will collaborate with R&D, Quality, Regulatory, and Operations to ensure assemblies meet safety, usability, and regulatory requirements throughout the product lifecycle.

The role requires strong knowledge of QSR, GMP, ISO standards, and DOE-based analysis, with a track record of delivering robust, cost-efficient packaging solutions.

Qualifications

• Bachelor's degree with 8+ years of experience in medical device packaging.
• Master's degree with 5+ years of experience.
• Doctoral degree with 3+ years of experience.
• Knowledge of ISO 11607, ISO 13485, FDA 21 CFR Part 820.

Responsibilities

• Lead planning, design, and improvement of packaging systems for sterile and non-sterile devices.
• Ensure packaging meets end-user, regulatory, and manufacturability requirements.
• Collaborate with R&D, Quality, Regulatory, and suppliers across product lifecycle.
• Develop concepts and provide direction for packaging strategies.
• Support validation activities, including OQ/PQ, and data-driven decisions.
• Prepare technical reports, protocols, and test results.

Skills

Packaging design

Cross-functional collaboration

Technical writing

Statistical analysis (DOE, ANOVA)

Quality systems understanding

Education

Bachelor's degree with 8+ years of experience

Master's degree with 5+ years of experience

Doctoral degree with 3+ years of experience

Tools

Microsoft Office

Job description

Integra LifeSciences is seeking a packaging engineer to lead the design and improvement of packaging systems for sterile and non-sterile medical devices. You will collaborate with R&D, Quality, Regulatory, and Operations to ensure assemblies meet safety, usability, and regulatory requirements throughout the product lifecycle.

The role requires strong knowledge of QSR, GMP, ISO standards, and DOE-based analysis, with a track record of delivering robust, cost-efficient packaging solutions.