Packaging Engineer; R&D
Job in
Columbus, Platte County, Nebraska, 68602, USA
Listed on 2025-12-25
Listing for:
TechDigital Group
Full Time
position Listed on 2025-12-25
Job specializations:
-
Engineering
Packaging Engineer, Quality Engineering, Biomedical Engineer
Job Description & How to Apply Below
Qualifications
- Rich experience as a package development engineer or a strong understanding of the package development process and responsibilities
- Working knowledge of 21
CFR Part 820 & EU MDR
-745/2017 regulations, as well as the requirement of Medical Device packaging standards per ISO
11607-1 & 2. - Expertise in Package qualification by performing various design verification tests, 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 21
CFRpart
820 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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