Packaging Engineer, DHF Remediation and End-of-Life Support

Job overview

The Packaging Engineer role is onsite in Warsaw, IN, for a stated 12-month duration; compensation is not specified. The position supports Packaging DHF Remediation and End-of-Life Support. The role establishes a baseline understanding of packaging-related design history file content and identifies gaps against regulatory and client requirements. Its assessments and remediation planning help stakeholders address documentation completeness and alignment with applicable standards and regulations.

What you'll do

• Review design history file documentation related to packaging design, materials, testing, labeling, and validation
• identify applicable standards and regulations, including ISO 13485, ISO 11607-1 and ISO 11607-2, 21 CFR 820, and EU MDR
• assess documentation completeness and compliance
• identify gaps in design inputs and outputs, validation, aging, and labeling
• coordinate with quality, regulatory, and project stakeholders
• prepare a packaging-focused assessment report, gap analysis matrix, regulatory alignment summary, and remediation plan and timeline.

What we're looking for

Skills & competencies

packaging engineer

warsaw in

artech

packaging dhf

dhf remediation

end-of-life support

iso 13485

iso 11607

21 cfr 820

eu mdr

packaging gap analysis

Work arrangement

• Weekend coverage required

Why this role

The posting specifies a 12-month duration and lists alternative education and experience combinations: bachelor’s degree plus one year of relevant experience, associate’s degree plus three years, or high school diploma/equivalent plus five years.

About the employer

Artech LLC is hiring for this role. Industry: Engineering Services. Sector: 54.