Sr Packaging Engineer – Medical Device

Overview

Title:
Sr Packaging Engineer – Medical Device

Location:
Lafayette, CO or North Haven, CT – Fully Onsite

Type: W2 Contract

Summary:

Experienced Packaging Engineer responsible for design, remediation, and validation of medical device packaging in compliance with ISO 11607 and industry standards. The role requires strong technical expertise, cross-functional collaboration, and the ability to lead projects from gap assessment through execution and final reporting.

• Lead validation of sterile and non-sterile medical device packaging systems in accordance with ISO 11607 Parts 1 & 2, ASTM, and ISTA standards.
• Conduct packaging gap analysis, develop remediation strategies, execute protocols, and author validation reports.
• Design and develop innovative packaging solutions considering product protection, regulatory requirements, cost, and manufacturability.
• Prepare and update packaging specifications, technical documentation, and labeling materials.
• Support regulatory audits and provide technical justifications for compliance.
• Lead project meetings, coordinate cross-functional teams, and communicate progress to management.
• Perform and evaluate laboratory package testing as required.

• Bachelor’s degree in Packaging Science, Mechanical Engineering, or related field.
• 5+ years of medical device or pharmaceutical packaging/quality engineering experience.
• Strong knowledge of ISO 11607, ASTM/ISTA test methods, and validation practices.
• Proficiency in Microsoft Office; CAD/CAPE/TOPS preferred.
• Excellent communication, teamwork, and project leadership skills.