Overview
Skills
Job Details
We are seeking a hands-on Packaging Engineer to support and lead medical device packaging development projects-focused on spinal implants and surgical instruments. The role involves managing OEM packaging activities and ensuring compliance with FDA, ISO, and MDR (EU) standards, especially for sterile packaging. This is a project-execution-driven role requiring strong cross-functional collaboration, risk management, and design documentation expertise.
Top Required Skills:-
Sterile Medical Device Packaging Development
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CAD Tools CREO or SolidWorks
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Project Management MS Project, DHF documentation, risk mitigation
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2+ years of experience in medical device packaging (4 7 preferred)
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Experience with electrically functional devices is a plus
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Strong understanding of sterilization methods (EtO, radiation, etc.)
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Proficiency in FDA/ISO packaging risk management
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Hands-on with CAD tools (CREO, SolidWorks)
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Skilled in Minitab/statistical analysis
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Familiar with DMAIC, 5 Whys, and other root-cause methodologies
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Proven experience managing cross-functional teams & project timelines
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Change control, equipment qualification, CSV
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Background in packaging/lab equipment commissioning
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Exposure to QA/QC processes and technical troubleshooting
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Design, develop, and validate sterile and non-sterile packaging
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Create and maintain Design History Files (DHF)
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Ensure packaging meets regulatory, QMS, and operational requirements
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Conduct risk assessments, root cause analysis, and documentation
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Collaborate with R&D, Quality, and Manufacturing to deliver safe, compliant packaging solutions