DHF Packaging Engineer II

Akkodis; Warsaw (IN); Hybrid; USD 55,000 - 76,000; Full time

Job summary

Akkodis is seeking a hybrid Medical Device Packaging Engineer II for a 12-month contract in Warsaw, IN. You will support packaging DHF remediation and EOL activities, establishing baseline DHF content and identifying gaps against regulatory requirements.

The role is $40-$55/hour with hybrid on-site work. Responsibilities include reviewing DHF docs, ensuring compliance with ISO 13485/11607, 21 CFR 820, EU MDR, and coordinating with QA/regulatory.

Qualifications

• Bachelor's Degree and 3+ years of relevant experience, or Associate's Degree and 5 years of relevant experience, or High School Diploma or Equivalent and 7 years of relevant experience in medical device or pharmaceutical manufacturing.
• Packaging-focused DHF assessment reporting.
• Experience with Packaging gap analysis matrix.
• Experience with Regulatory and standards alignment summary.
• Packaging remediation plans and timelines exposure.
• Ability to travel domestically 20%, then hybrid schedule in Warsaw, IN otherwise.

Responsibilities

• Review existing DHF documentation related to packaging design, materials, testing, labeling, and validation
• Identify applicable standards and regulations (e.g., ISO 13485, ISO 11607-1 and ISO 11607-2, 21 CFR 820, EU MDR)
• Assess completeness and compliance of packaging documentation within the DHF
• Identify gaps related to packaging design inputs/outputs, validation, aging, and labeling
• Coordinate with quality, regulatory, and project stakeholders to confirm expectations

Skills

Packaging-focused DHF assessment

Packaging gap analysis

Regulatory and standards alignment

Packaging remediation plans

Education

Bachelor's Degree + 3+ years

Associate's Degree + 5 years

High School Diploma + 7 years

Job description

Akkodis is seeking a hybrid Medical Device Packaging Engineer II for a 12-month contract in Warsaw, IN. You will support packaging DHF remediation and EOL activities, establishing baseline DHF content and identifying gaps against regulatory requirements.

The role is $40-$55/hour with hybrid on-site work. Responsibilities include reviewing DHF docs, ensuring compliance with ISO 13485/11607, 21 CFR 820, EU MDR, and coordinating with QA/regulatory.