Packaging Engineer

Packaging Engineer III (Medical Devices) Location: Mansfield, MA Duration: Long Term 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. The ideal candidate will have strong expertise in medical device packaging, package validation, and sterilization processes, with specific knowledge of EO (Ethylene Oxide) sterilization interactions with packaging systems. Key Responsibilities Packaging Development & Design 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. Packaging Testing & Compliance Assist with operation of the package testing laboratory, including sample preparation, testing, and reporting. Ensure compliance with FDA, ISO, ASTM, and ISTA packaging standards. Perform risk assessments and root cause investigations related to packaging performance. Maintain packaging documentation and Design History File (DHF) deliverables. 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. #J-18808-Ljbffr Stark Pharma Solutions Inc