Packaging​/Labeling Engineer

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This position serves as the packaging and labeling subject matter expert responsible for defining, designing, verifying, and documenting all packaging and labeling solutions for a complex medical device system, including capital equipment, reusables, disposables, and multi-component kits. This role requires a high level of autonomy, technical depth, and familiarity with medical device regulatory requirements.

• Serve as the sole subject matter expert for packaging design across capital, reusable, disposable, and kit-based device configurations.
• Develop protective packaging solutions in compliance with applicable packaging, distribution, and sterilization standards.
• Create packaging specifications, drawings, CAD models, and BOMs for all packaging components.
• Select materials and evaluate designs based on performance, manufacturability, and cost.
• Integrate packaging with sterilization, reprocessing, storage, and clinical workflow requirements.
• Develop regulatory, operational, and shipping labels for all system components.
• Confirm labeling content and artwork alignment with FDA 21 CFR 801, EU MDR Annex I (GSPR 23), ISO
  -1, ISO, UDI/GS1, and IEC/UL marking requirements.
• Identify appropriate marking technologies/materials to meet IEC and ISO Durability and Legibility requirements.
• Systematically approach labeling with preparedness for global launch and translations.
• Create and maintain controlled artwork and label templates within the document control system for in-house manufacturing.
• Guide execution of labeling by contract manufacturers and consult on materials or marking technologies.
• Plan and execute packaging validation activities, including aging studies, sterile barrier evaluations, and distribution simulation.
• Develop verification protocols and reports for packaging.
• Ensure traceability of packaging and labeling within the design control framework.

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or related discipline.
• 5–10+ years of experience in medical device packaging and labeling engineering.
• Strong knowledge of ISO and relevant standards.
• Experience designing and verifying packaging for capital equipment, reusables, and disposables.
• Experience with multiple marking technologies for capital and reusable equipment.
• Working knowledge of FDA 21 CFR 801, EU MDR GSPR 23, ISO
  -1, ISO, UDI/GS1, and IEC/UL requirements.
• Proficiency with label creation software, such as Nice Label, and operation of labeling equipment.
• Excellent communication skills and ability to work independently.

• Familiarity with packaging redlining.
• Ability to contribute to regulatory submissions by providing labeling content, UDI strategy, packaging validation evidence, and hazard mitigation information.

This position is 100% on-site and involves working independently and communicating with suppliers.

Contract to Hire position based out of Maple Grove, MN.

Pay range: $45.00 - $75.00/hr.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market.

All Actalent locations are full‑time, permanent, and offer EEO benefits. Actalent values diversity and is an equal opportunity employer. If you would like to request a reasonable accommodation, please email actalentaccom for additional options.