Title : Senior Packaging Engineer Product Development
Location: Mansfield, MA 100% Onsite
Employment Type: Contract W2
Duration: 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.