Senior Medical Device Packaging Engineer - Onsite, Contract

Intellectt INC; Boston (MA); On-site; USD 55,000 - 68,000; Full time

Job summary

Intellectt INC is seeking a Senior Packaging Engineer Product Development in Mansfield, MA. This onsite contract role focuses on packaging development for sterile and non-sterile medical devices, including validation, sustaining, and continuous improvement from R&D through commercialization.

You will lead packaging projects, evaluate materials and processes, and ensure compliance with ISO standards and FDA regulations. Strong technical writing and cross-functional collaboration are essential.

Qualifications

• Bachelor's degree in Packaging Engineering or related field.
• 3-5+ years in medical device packaging; advanced degree may be considered.
• Direct Medical Device industry experience.
• Strong understanding of EO sterilization interactions.
• Hands-on packaging development for sterile devices.
• Experience with thermoformed trays, pouches, sealing equipment.
• Experience developing and executing packaging verification and validation protocols.
• Experience with packaging process qualification (IQ/OQ/PQ).
• Knowledge of ISO 11607, FDA 21 CFR Part 820, and ISTA requirements.
• Experience with documentation, testing, and data analysis.
• Experience working with cross-functional teams in regulated environments.
• Strong technical writing, communication, prioritization, and problem-solving skills.

Responsibilities

• Lead planning, design, development, validation, and improvement of packaging systems.
• Develop packaging specifications, test plans, protocols, and reports.
• Support NPI, sustaining, and continuous improvement projects.
• Lead packaging projects across R&D, Quality, Regulatory, and Operations teams.
• Evaluate materials, structures, components, and conversion processes.
• Support packaging systems for sterile and non-sterile devices.
• Evaluate EO sterilization interactions and impacts on packaging performance.
• Develop and execute packaging design verification and validation activities.
• Support packaging testing including sample prep, data analysis and reporting.
• Develop qualification strategies and execute IQ/OQ/PQ activities.
• Analyze test data, identify root causes, and develop conclusions.
• Support packaging tooling and equipment development, project schedules, cost tracking.
• Assist with packaging lab activities and maintain testing records.
• Apply risk analysis and design/manufacturing methodologies to packaging development.
• Drive packaging best practices, quality, sustainability, usability, and cost-effectiveness.

Skills

Technical writing

Communication

Prioritization

Problem solving

Education

Bachelor's degree in Packaging Engineering

Job description

Intellectt INC is seeking a Senior Packaging Engineer Product Development in Mansfield, MA. This onsite contract role focuses on packaging development for sterile and non-sterile medical devices, including validation, sustaining, and continuous improvement from R&D through commercialization.

You will lead packaging projects, evaluate materials and processes, and ensure compliance with ISO standards and FDA regulations. Strong technical writing and cross-functional collaboration are essential.