Senior Medical Device Packaging Engineer – NPI & Innovation

INTEGRA LIFESCIENCES CORP; Columbia (MD); On-site; USD 82,000 - 113,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) plan

Job summary

Integra LifeSciences is seeking an experienced Packaging Engineer to lead the development and improvement of packaging systems for sterile and non‑sterile medical devices. You will ensure packaging meets safety, regulatory, and manufacturing requirements while collaborating with R&D, Quality, Regulatory, and Operations teams.

The role requires strong knowledge of QSR, GMP, ISO standards, and statistical methods, with the ability to manage multiple tasks and guide junior engineers.

Qualifications

• Strong knowledge of QSR, GMP, Design Controls, and basic Process Validation principles in medical devices.
• Familiar with FDA, ISO, ASTM, ISTA packaging and labeling standards including ISO 11607 parts 1 and 2.
• Ability to read engineering drawings with GD&T exposure.
• Capability to manage multiple tasks with guidance and evolving independence.
• Solid knowledge of DOE, ANOVA, capability analysis and related statistical methods.

Responsibilities

• Lead design and improvement of package systems for sterile and non‑sterile devices.
• Ensure packaging meets safety, manufacturability, regulatory and sustainability requirements.
• Collaborate with R&D, Quality, Regulatory, Labeling, Operations and suppliers.
• Plan and execute DOE activities and document results.
• Prepare and review protocols, test reports and specifications.
• Mentor junior engineers and coordinate small projects.

Skills

QSR knowledge

GMP knowledge

Design Controls

Statistical analysis

Technical writing

Cross-functional collaboration

Education

Bachelor degree with 5+ years

Master degree with 3+ years

Doctoral degree with 0-2 years

Tools

Microsoft Office

Job description

Integra LifeSciences is seeking an experienced Packaging Engineer to lead the development and improvement of packaging systems for sterile and non‑sterile medical devices. You will ensure packaging meets safety, regulatory, and manufacturing requirements while collaborating with R&D, Quality, Regulatory, and Operations teams.

The role requires strong knowledge of QSR, GMP, ISO standards, and statistical methods, with the ability to manage multiple tasks and guide junior engineers.