Packaging Engineer

Position Overview

We are seeking an experienced Packaging Engineer III to support product development, packaging design, validation, and commercialization activities for sterile and non-sterile medical devices. This role will lead packaging initiatives across new product introductions (NPI), sustaining engineering, and continuous improvement projects while collaborating with cross-functional teams in a regulated medical device environment.

Key Responsibilities

• Lead the design, development, validation, and implementation of packaging systems for sterile and non-sterile medical devices.
• Define packaging requirements related to functionality, safety, manufacturability, regulatory compliance, sustainability, and business objectives.
• Collaborate with R&D, Quality, Regulatory, Operations, Labeling, and suppliers throughout the product lifecycle.
• Support new product development, product transfers, and packaging improvements.

Verification & Validation

• Develop and execute package validation strategies, including Design Verification (DV), Design Validation (DVal), and Packaging Process Validation activities.
• Author test plans, protocols, reports, IQ/OQ/PQ documentation, and technical specifications.
• Conduct package performance testing, data analysis, and statistical evaluations.
• Support packaging equipment qualification and process characterization activities.

Project Leadership

• Lead packaging workstreams within cross-functional development teams.
• Coordinate project schedules, tooling requirements, equipment needs, and supplier activities.
• Drive continuous improvement initiatives focused on quality, cost, efficiency, and standardization.

Required Qualifications

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, Materials Science, or related technical discipline.
• 5+ years of packaging engineering experience within the medical device industry.
• Strong knowledge of sterile barrier systems, thermoform trays, pouches, sealing technologies, and packaging materials.
• Experience supporting EO sterilization and understanding its impact on packaging systems.
• Hands-on experience with packaging validation, package testing, and process qualification activities.
• Knowledge of: ISO 11607, FDA 21 CFR Part 820, ISO 13485, ASTM & ISTA Packaging Standards.
• Experience developing technical specifications and engineering documentation.
• Strong analytical, project management, and problem-solving skills.