S
Not Specified Permanent

Warsaw, Indiana · USA job

Packaging Engineer

Synkriom

Warsaw, Indiana

Job description

Job Description Job Description

Packaging Engineer supporting packaging DHF Remediation and EOL support
Objective: Establish a baseline understanding of packaging-related DHF content and identify gaps relative to regulatory
Activities:
a.
Review existing DHF documentation related to packaging design, materials, testing, labeling, and validation
b.
Identify applicable standards and regulations (e.g., ISO 13485, ISO 11607-1 and ISO 11607-2, 21 CFR 820, EU MDR)
c.
Assess completeness and compliance of packaging documentation within the DHF
d.
Identify gaps related to packaging design inputs/outputs, validation, aging, and labeling
e.
Coordinate with quality, regulatory, and project stakeholders to confirm expectations

Skills:

Deliverables:
(a)
Packaging-focused DHF assessment report
(b)
Packaging gap analysis matrix
(c)
Regulatory and standards alignment summary
(d)
Packaging remediation plan and timeline

Education:

Bachelor's Degree and 1 years of relevant experience, or Associate's Degree and 3 years of relevant experience, or High School Diploma or Equivalent and 5 years of relevant experience

Company Description

Founded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.

Company Description Founded in 2015 and backed by two decades of hands-on experience, our strong insight on the enterprise ecosystem and its dynamics helps to offer a complete end-to-end solution. We automate recruitment processes with intelligent solutions to save time and money. Synkriom leads the industry with experience authentication of candidates.

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