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.
Numbers & Facts
Location
Columbus, NE
Industry
Other/Not Classified
Company Size
100 to 499 employees
Skills
Code of Federal Regulationsunmatched
Design Verificationunmatched
FDA (Food and Drug Administration)unmatched
ISO (International Organization for Standardization)unmatched
Medical Disposablesunmatched
Medical Equipmentunmatched
Medical Protocolsunmatched
Order Picking/Packingunmatched
Product Packagingunmatched
Regulationsunmatched
Research & Development (R&D)unmatched
Sterilizationunmatched
Test Designunmatched
Test Requirementsunmatched
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