Packaging Engineer (R&D) -Medical Device Job at Yochana IT, Columbus, NE

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  • Yochana IT
  • Columbus, NE

Job Description

Title:Packaging Engineer (R&D) Onsite-Medical Device
Location:Columbus, NE

VISA: ANY VISA



JD:

  • 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.

Bharath Kumar

Yochana

23000 Commerce Dr., Farmington hills, MI-48335

[email protected]

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