Novozen Healthcare LLC · 8 hours ago
Packaging Engineer
Minnesota, United States
Contract
Onsite
Mid Level
4+ years expNovozen Healthcare LLC is seeking a Packaging Engineer responsible for designing, developing, validating, and maintaining packaging systems for medical devices. The role involves ensuring product safety and compliance with regulatory standards while supporting new product development and sustaining engineering activities.
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Hiring Manager
TARUN KUMAR
Responsibilities
Design and develop primary, secondary, and tertiary packaging solutions for medical devices, including sterile barrier systems
Lead and execute packaging validations per ISO 11607, including IQ/OQ/PQ, transit testing, and shelf-life studies
Support new product development (NPD) by defining packaging requirements and ensuring design transfer to manufacturing
Perform packaging risk assessments, FMEA, and material compatibility evaluations
Author and review packaging specifications, protocols, reports, SOPs, and test methods
Coordinate with cross-functional teams including R&D, Quality, Validation, Manufacturing, Regulatory, and Suppliers
Support change control activities, including packaging changes, supplier changes, and material updates
Conduct packaging investigations, root cause analysis, and implement CAPA for packaging-related issues
Ensure compliance with FDA QSR (21 CFR 820), ISO 13485, GMP, and internal quality standards
Support audits (internal, supplier, and regulatory) related to packaging systems
Evaluate and qualify packaging suppliers and materials
Qualification
Required
Bachelor's degree in Packaging Engineering, Mechanical Engineering, Industrial Engineering, or related field
4+ years of experience as a Packaging Engineer in the medical device industry
Strong knowledge of ISO 11607, FDA QSR, ISO 13485, and GMP requirements
Hands-on experience with packaging validation, sterile barrier systems, and transit testing
Experience with document control, change management, and design control processes
Ability to manage multiple projects in a regulated environment
Preferred
Experience with sterile medical devices (ETO, Gamma, or Steam sterilization)
Familiarity with ASTM packaging and transportation standards (e.g., ASTM D4169, ISTA)
Experience working with contract manufacturers and packaging vendors
Strong technical writing and communication skills
Company
Novozen Healthcare LLC
At Novozen Healthcare, we excel in bridging the gap between academics and industry.
201-500 employees
H1B Sponsorship
Novozen Healthcare LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (47)
2024 (34)
2023 (20)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Vijay Kumar
Sr. Recruitment Partner
Company data provided by crunchbase