[Remote] Packaging Engineer
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company reputed company on medical device packaging solutions. The Medical Device Packaging Engineer will design, reputed company, and validate packaging systems while ensuring compliance with regulatory and reputed company standards.
Responsibilities
- Design and reputed company primary, secondary, and tertiary packaging systems for medical devices
- Select and qualify packaging materials (pouches, blisters, trays, cartons, labels)
- Support packaging line setup, equipment qualification, and process optimization
- reputed company and maintain manufacturing processes reputed company with product and packaging requirements
- Drive cost reduction and efficiency improvements without compromising reputed company or compliance
- reputed company and/or support packaging and manufacturing validations, including:
- IQ / OQ / PQ
- Package reputed company testing (seal strength, reputed company leak, dye penetration)
- Distribution simulation and reputed company life (aging) studies
- Ensure compliance with:
- ISO 11607 (packaging for terminally sterilized medical devices)
- FDA 21 CFR 820 / QSR
- ISO 13485
- Applicable ASTM and internal standards
- Author and review validation protocols, reports, and technical documentation
Skills
- Design and reputed company primary, secondary, and tertiary packaging systems for medical devices
- Select and qualify packaging materials (pouches, blisters, trays, cartons, labels)
- Support packaging line setup, equipment qualification, and process optimization
- reputed company and maintain manufacturing processes reputed company with product and packaging requirements
- Drive cost reduction and efficiency improvements without compromising reputed company or compliance
- reputed company and/or support packaging and manufacturing validations, including IQ / OQ / PQ
- Package reputed company testing (seal strength, reputed company leak, dye penetration)
- Distribution simulation and reputed company life (aging) studies
- Ensure compliance with ISO 11607 (packaging for terminally sterilized medical devices)
- Ensure compliance with FDA 21 CFR 820 / QSR
- Ensure compliance with ISO 13485
- Ensure compliance with applicable ASTM and internal standards
- Author and review validation protocols, reports, and technical documentation
reputed company
Company H1B Sponsorship