Senior Packaging Engineer

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

Title : Senior Packaging Engineer Product Development

Location: Mansfield, MA 100% OnsiteEmployment Type: Contract W2Duration: 6+ Months

About the Role

We are seeking a Senior Packaging Engineer to support packaging development, validation, sustaining, and continuous improvement projects for sterile and non-sterile medical devices. This role will work closely with R&D, Quality, Regulatory, Operations, suppliers, and other cross-functional teams from early development through commercialization.

Key Responsibilities

• Lead the planning, design, development, validation, and improvement of medical device packaging systems.
• Develop packaging specifications, design requirements, test plans, protocols, reports, and technical documentation.
• Support New Product Introduction (NPI), sustaining, and continuous improvement projects.
• Lead packaging projects across R&D, Quality, Regulatory, Operations, Labeling, suppliers, and manufacturing teams.
• Evaluate packaging materials, structures, components, and conversion processes.
• Support packaging systems for both sterile and non-sterile medical devices.
• Evaluate EO sterilization interactions with packaging and assess impacts on packaging performance and integrity.
• Develop and execute packaging design verification and validation activities.
• Support package testing including sample preparation, test execution, data analysis, and reporting.
• Develop packaging process qualification strategies and execute Process Characterization, IQ, OQ, and PQ activities.
• Analyze test data, identify root causes, and develop data-driven technical conclusions.
• Support packaging tooling and equipment development, including project schedules and cost tracking.
• Assist with packaging laboratory activities and maintain complete testing and project records.
• Apply risk analysis, design/manufacturing methodologies, and statistical approaches to packaging development.
• Drive packaging best practices, standard work, quality, sustainability, usability, and cost-effectiveness initiatives.

Required Qualifications

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

Salary

The salary/rate for this position is $40-$49/hr based on experience and qualifications.

Benefits:

This is a contract position and does not include employer-provided benefits.

Equal Opportunity Employer:

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check:

Background checks may be conducted in accordance with applicable law.

Work Authorization:

Applicants must be authorized to work in the United States.