Packaging Engineer

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