Packaging Engineer (R&D)

TechDigital

  • Columbus, NE
  • 2 days ago

    Highlights

    Expertise in Package qualification by performing various design verification testings' such as Package integrity, Seal strength, Microbial barrier, Ink Legibility & Performance, Box compression, Label Adhesion and Ship tests etc., for disposable medical devices (hypodermic syringes, needles etc. ) Per ISO 11607 in accordance with ISO 13485 / US FDA 21CFR part820 requirement. Exposure to various sterilization techniques and experienced in sterilization requirements for various medical device-packaging materials.

    Numbers & Facts

    LocationColumbus, NE
    IndustryOther/Not Classified
    Company Size100 to 499 employees

    Description

    • Rich experience as a package development engineer or a strong understanding of the package development process and responsibilities
    • Working knowledge of 21CFR Part 820 & EU MDR -745/2017 regulations, as well as the requirement of Medical Device packaging standards per ISO11607-1 & 2.
    • Expertise in Package qualification by performing various design verification testings' such as Package integrity, Seal strength, Microbial barrier, Ink Legibility & Performance, Box compression, Label Adhesion and Ship tests etc., for disposable medical devices (hypodermic syringes, needles etc...) Per ISO 11607 in accordance with ISO 13485 / US FDA 21CFR part820 requirement.
    • Extensive knowledge on Medical Device packaging shipping container distribution test requirements per ASTM 4169/ ISTA standards
    • Exposure to various sterilization techniques and experienced in sterilization requirements for various medical device-packaging materials.

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