Senior Medical Device Packaging Engineer

Integra-Lifesciences; Maryland; On-site; USD 81,650 - 112,700; Full time

Job summary

Integra LifeSciences is seeking an experienced packaging engineer to lead the design, development, and improvement of packaging systems for sterile and non-sterile medical devices. You will work across R&D, Quality, Regulatory, and Operations to ensure packaging meets safety, functionality, and regulatory standards.

The role requires strong knowledge of QSR/GMP, ISO/ISTA standards, and GD&T drawing interpretation, with experience in DOE and other statistical methods to support decisions.

Qualifications

• Strong knowledge of QSR, GMP, Design Controls, and basic Process Validation in the medical device industry.
• Familiarity with FDA, ISO, ASTM, ISTA requirements for packaging and labeling, ISO 11607, ISO 13485, ISO 14971.
• Ability to read and interpret engineering drawings with GD&T concepts.
• Experience applying statistical analysis methods (DOE, ANOVA, capability analysis, histograms, normality testing) to engineering decisions.

Responsibilities

• Lead planning, design, development, and improvement of packaging systems for sterile and non-sterile devices.
• Ensure packaging meets end-user functionality, safety, manufacturability, regulatory compliance, and sustainability requirements.
• Collaborate cross-functionally with R&D, Quality, Regulatory, Labeling, Operations and suppliers.
• Develop and review technical reports, protocols, and documentation summarizing test results and conclusions.
• Provide guidance to junior engineers and lead small project teams.

Skills

QSR & GMP

Design Controls

FDA/ISO/ISTA standards

Packaging materials knowledge

DOE & statistical methods

Technical writing

Cross-functional collaboration

GD&T interpretation

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Doctoral degree in Engineering

Tools

MS Office

Excel

Microsoft Project

Statistical software

Job description

Integra LifeSciences is seeking an experienced packaging engineer to lead the design, development, and improvement of packaging systems for sterile and non-sterile medical devices. You will work across R&D, Quality, Regulatory, and Operations to ensure packaging meets safety, functionality, and regulatory standards.

The role requires strong knowledge of QSR/GMP, ISO/ISTA standards, and GD&T drawing interpretation, with experience in DOE and other statistical methods to support decisions.