Label & Kit Design Specialist IV (IVD/Medical Devices)

Abbott; Madison (WI); On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott in Madison, WI seeks a Design Associate IV to assist in labeling and kit design transfer, documentation, validation, and production implementation. This role requires onsite presence in Madison up to four days per week and collaboration across Production, QA, Regulatory, and Supply Chain teams.

The candidate will support development, validation batches, and procedure compliance in a heavily regulated IVD/ RUO manufacturing environment.

Qualifications

• Bachelor’s degree required in Biology, Chemistry, or life science; equivalent experience may be considered.
• 1+ years in daily operations, SOP documentation, and instrument use in regulated biotech environments.
• Proficient in Microsoft Office Suite.
• Authorized to work in the United States without sponsorship.

Responsibilities

• Assist in design transfer and labeling/kitting processes for IVD/ RUO products.
• Develop templates, SOPs, and GMP labeling/kitting documents per standards.
• Support BOM changes and part number implementations.
• Coordinate with Production, QA, Regulatory, and Supply Chain functions.
• Travel between Madison locations up to 5% as needed.

Skills

Office software

Attention to detail

Communication

Education

Bachelor’s degree in Biology or life science

Tools

Lab instruments

Job description

Abbott in Madison, WI seeks a Design Associate IV to assist in labeling and kit design transfer, documentation, validation, and production implementation. This role requires onsite presence in Madison up to four days per week and collaboration across Production, QA, Regulatory, and Supply Chain teams.

The candidate will support development, validation batches, and procedure compliance in a heavily regulated IVD/ RUO manufacturing environment.