Packaging Engineer I

Job Title: Packaging Engineer I

Location: Warsaw, IN 4658

Duration: 12 Months

Job Type: Temporary Assignment

Work Type:Onsite

Pay Rate: $55.00 - $55.00/Hr

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses. Client has operations in more than 40 countries around the world.

Job Description:

Duties:

• 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 and Client requirements.

Activities:

• 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:

Deliverables:

• Packaging-focused DHF assessment report
• Packaging gap analysis matrix
• Regulatory and standards alignment summary
• 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

TekWissen® Group is an equal opportunity employer supporting workforce diversity.