Job Title: Senior Packaging Engineer
Location: Boston, MA
Duration: 12+ Months
Experience: 5 Years
Job Summary:
We are seeking an experienced Senior Packaging Engineer with a strong background in medical device packaging to support design, validation, and compliance activities. The ideal candidate will bring hands-on expertise in sterile packaging systems, labeling, and regulatory standards, along with the ability to drive packaging improvements and compliance initiatives.
Key Responsibilities:
- Design and develop medical device packaging systems, including material selection and sterile barrier systems
- Lead and execute packaging validation activities including IQ/OQ/PQ, transit testing, and aging studies
- Ensure compliance with medical device labeling requirements, including UDI (Unique Device Identification)
- Implement and validate barcode systems in alignment with GS1 standards
- Support regulatory compliance efforts with FDA and ISO standards (ISO 13485, ISO 11607)
- Collaborate with cross-functional teams including Quality, Regulatory, Manufacturing, and Supply Chain
- Participate in packaging remediation projects and continuous improvement initiatives
- Assist in post-acquisition integration activities related to packaging and labeling
- Manage label conversions, barcode updates, and compliance gap assessments
Required Qualifications:
- Bachelor’s degree in Engineering or a related field
- 5–10 years of experience in medical device packaging engineering
- Strong expertise in packaging design and sterile barrier systems
- Hands-on experience with packaging validation (IQ/OQ/PQ, transit testing, aging studies)
- Experience with UDI, labeling compliance, and barcode implementation
- Working knowledge of GS1 standards
- Familiarity with FDA regulations and ISO standards (ISO 13485, ISO 11607)
Preferred Qualifications:
- Experience with post-acquisition integration projects
- Background in packaging remediation and compliance gap closure
- Experience with label conversions and barcode updates
- Ability to work in fast-paced, cross-functional environments