Hybrid Medical Device 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 job with a client in Warsaw, IN. You will be supporting packaging DHF Remediation and EOL support. You will establish a baseline understanding of packaging-related DHF content and identify gaps relative to regulatory and Company requirements.

Rate Range: $40.00/hour to $55.00/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Hybrid Medical Device Packaging Engineer II job responsibilities include:

• 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

Desired Qualifications:

• Bachelor's Degree and 3+ year 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.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

The California Fair Chance Act

Los Angeles City Fair Chance Ordinance

Los Angeles County Fair Chance Ordinance for Employers