Senior Packaging Engineer (Hybrid)
Date de publication :
07 octobre 2024Taux d'activité :
100%Type de contrat :
Durée indéterminée- Lieu de travail :Arroyo
What you will do:
As a Senior Packaging Engineer, you will collaborate with both the NPD and Sustaining teams to design, manage, improve, and maintenance of sterile and non-sterile packaging. You will be responsible for designing and implementing new or revised packaging for medical devices, developing and issuing detailed specifications for procurement of packaging components, and ensuring the integrity of the packaging design through comprehensive testing following industry standards.
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Independently research, design, and develop packaging components, modules, and sub-systems for medical devices, ensuring quality and effectiveness.
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Oversee sterile and non-sterile packaging from initial design through protocol writing, execution, and test report authoring, collaborating with internal teams and external partners.
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Translate user needs into packaging design specifications and work with cross-functional teams to incorporate customer inputs.
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Drive packaging design changes for enhanced product quality, environmental sustainability, and cost efficiency.
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Ensure packaging validation work instructions comply with industry standards, FDA requirements, and internal protocols.
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Perform root cause analysis and own packaging-related non-conformities (NCs) and corrective actions (CAPAs).
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Work with teams in quality, manufacturing, regulatory, and marketing to ensure project success and participate in interdepartmental meetings and trainings.
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Provide guidance on packaging design and testing, evaluate packaging tooling and equipment, and maintain packaging prints.
What you need:
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Bachelor’s degree in Packaging Engineering/Packaging Science (preferred), Mechanical Engineering, Material Science, or Biomedical Engineering
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3+ years of relevant industry experience: Medical or regulated industry
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Demonstrated technical ability with SolidWorks (or similar CAD software)
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Packaging and design engineering experience
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Understanding of ASTM International packaging standards and test methods, ISO 11607 packaging standards for sterile medical devices and ISO2233 packaging conditions standard