Job Description

Packaging/Labeling Engineer

Job Description:

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.

Responsibilities:

• 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.

Essential Skills:

• 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 NiceLabel, and operation of labeling equipment.

• Excellent communication skills and ability to work independently.

Additional Skills & Qualifications:

• Familiarity with packaging redlining.

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

Work Environment:

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

Job Type & Location

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

Pay and Benefits

The pay range for this position is $45.00 - $75.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - 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)

Workplace Type

This is a fully onsite position in Maple Grove,MN.

Application Deadline

This position is anticipated to close on Jan 5, 2026.

About Actalent

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. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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