Packaging Engineer (R&D)

TechDigital Group; Columbus (NE); Vor Ort; USD 80.000 - 110.000; Vollzeit

Zusammenfassung

A leading packaging solutions company in Columbus, Nebraska, is looking for an experienced Package Development Engineer. The role requires a deep understanding of regulatory requirements for medical device packaging, as well as expertise in design verification tests for disposable medical devices. Ideal candidates should have rich experience in the packaging development process and knowledge of sterilization techniques.

Qualifikationen

• Rich experience as a package development engineer or strong understanding of the package development process.
• Working knowledge of 21CFR Part 820 & EU MDR -745/2017 regulations.
• Expertise in Package qualification and various design verification tests.
• Familiarity with ASTM 4169/ISTA test shipping requirements.
• Exposure to sterilization techniques for medical device packaging materials.

Kenntnisse

Package development process understanding

Knowledge of Medical Device packaging standards

Expertise in design verification tests

Knowledge of sterilization techniques

Sterilization knowledge

Medical device packaging

Tools

ISTA standards

ASTM 4169

Jobbeschreibung

Qualifications

• 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 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 21CFRpart820 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.