Packaging Engineer (R&D) Onsite-Medical Device - Sira Consulting, an Inc 5000 company : Job Details

• 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.