Lead Packaging Systems Engineer, Medical Devices

Integra LifeSciences; Columbia (MD); On-site; USD 81,650 - 112,700; Full time

Job summary

Integra LifeSciences is seeking a senior packaging engineer in Maryland to lead the planning, design, and improvement of package systems for medical devices. You will collaborate with R&D, Quality, Regulatory, and Operations to ensure end-to-end packaging success, including design controls and risk management.

The role requires strong knowledge of QSR/GMP, ISO 11607, and FDA/ISO standards, with hands-on experience in packaging materials and validation.

Qualifications

• Experience with QSR, GMP, and Design Controls in medical devices.
• Familiarity with ISO 11607, FDA/ISO labeling standards and regulatory references.
• Ability to read engineering drawings and apply GD&T.

Responsibilities

• Lead planning, design, development, and improvement of package systems.
• Ensure packaging meets requirements for safety, manufacturability, and regulatory compliance.
• Collaborate cross-functionally to drive packaging lifecycle activities.
• Develop and evaluate packaging concepts with direction and recommendations.
• Support validation activities including OQ/PQ execution.
• Prepare technical reports, protocols, and documentation.

Skills

QSR/GMP knowledge

Design Controls

FDA/ISO awareness

Packaging knowledge

GD&T reading

Technical writing

Cross-functional collaboration

DOE/Statistical methods

Regulatory compliance

Risk assessment

Education

Bachelor's degree with 8+ years experience

Master's degree with 5+ years experience

Doctoral degree with 3+ years experience

Tools

MS Office

Statistical tools

Job description

Integra LifeSciences is seeking a senior packaging engineer in Maryland to lead the planning, design, and improvement of package systems for medical devices. You will collaborate with R&D, Quality, Regulatory, and Operations to ensure end-to-end packaging success, including design controls and risk management.

The role requires strong knowledge of QSR/GMP, ISO 11607, and FDA/ISO standards, with hands-on experience in packaging materials and validation.