Nextern

Designs and manufactures medical devices

Labeling Specialist

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours

Full-timeMaple Grove, MN, USA$70k - $100k /yrIn-person

About the Job

Requirements

A degree in graphic design, communication, business, or equivalent is required.
At least 3 years of experience in a Labeling Specialist role is required.
Experience working in quality systems as defined in 21 CFR 820 and ISO 13485 is required.
Understanding of ISO 14971 and the application of risk management to product development and processes is required.
Familiarity with medical device industry-specific labeling requirements is required.
Understanding of configuration management in relation to variable data and label templates is required.
Familiarity with harmonized and recognized test standards for labeling is required.
Experience using barcoding systems such as GS1 and HIBC-128 is required.
Proficiency in label design and management software such as BarTender and GSI Data Hub is required.
Demonstrated use of quality tools and methodologies, including nonconformance, corrective and preventive actions (CAPAs), and root cause analysis, is required.
Experience with Product Lifecycle Management (PLM) software such as Windchill, Agile, or Propel is required.
Experience with Enterprise Resource Planning (ERP) software such as Epicor or NetSuite is required.
Intermediate to advanced proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Project, and Outlook, is required.

Responsibilities

Serve as a development project team member accountable for label design across several programs simultaneously.
Coordinate and execute label verification activities as necessary.
Support label print station qualifications.
Review, assess, and approve design and process changes to existing package and label designs or processes.
Lead and coordinate labeling activities for new product launches, market expansions, and regulatory updates across departments.
Act as liaison to label raw material and equipment suppliers.
Serve as the organizational subject-matter expert for labeling requirements, including audits.
Draft and own labeling processes, guidelines, templates, and forms within the Quality System.
Develop and validate label print artwork files and printing processes as necessary.
Create and maintain up-to-date product Design History Files (DHF).
Interface between manufacturing/PLM and supply chain/ERP to ensure batch-specific information, such as lot and serial numbers, is accurate across systems.
Develop, validate, and implement label designs for finished medical devices.
Align label designs with device risk management files and relevant regulatory requirements.
Identify label printing process controls to ensure printed content is accurate and transfer labeling into commercial manufacturing.
Perform sustaining labeling activities, including changes and impact assessments, global regulatory compliance, nonconformances and complaints, and process improvement.
Comply with the Quality System, regulations, and standards; support continuous improvement and professionally interact with Nextern customers as needed.

Desired Qualifications

Global experience is preferred.

Labeling Specialist

Nextern · Maple Grove, United States · Full-time · Posted 2026-10-15

Salary: USD 70,000–100,000

Workplace: on_site

Department: Quality Assurance

Description

At Nextern, we inspire with passion, impact with significance, and act with integrity. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. From single-use disposables to fully integrated systems to precision components, our teams work as an extension of yours to solve patient needs and improve lives worldwide.

This role is responsible for the development, validation, and implementation of label designs for finished medical devices developed by Nextern. Labeling Specialists are members of product development teams, utilizing their expertise to develop label designs aligning with device risk management files and relevant regulatory requirements, identify label printing process controls to ensure printed content is accurate, and ultimately transfer into commercial manufacturing. This role is also responsible for sustaining activities related to labeling including, but not limited to: changes and impact assessments, global regulatory compliance, nonconformances and complaints, and process improvement. All functions are responsible for compliance with the Quality System, regulations and standards, continuous improvement, and as needed, professional interaction with Nextern Customers.

RESPONSIBILITIES

Development project team member accountable for label design across several programs simultaneously
Coordinate and execute, as necessary, label verification activities
Support label print station qualifications
Review, assess, and approve design and process changes to existing package and label designs or processes
Lead and coordinate labeling activities for new product launches, market expansions, and regulatory updates across departments
Liaison to label raw material and equipment suppliers
Serve as organizational SME for labeling requirements, including audits
Draft/own labeling processes, guidelines, templates, and forms within the Quality System
Develop and validate, as necessary, label print artwork files and printing process
Create and maintain up-to-date product Design History Files (DHF)
Interface between manufacturing/PLM and supply chain/ERP ensuring batch specific (i.e. lot/serial number) information is accurate across systems

Requirements

QUALIFICATIONS

Required:

Degree in graphic design, communication, business, or equivalent
3+ years of experience in a Labeling Specialist role
Experience working in quality systems as defined in 21 CFR 820 and ISO 13485.
Understanding of ISO 14971 and application of risk management to product development and processes
Familiarity with medical device industry specific labeling requirements
Understanding of configuration management in relation to variable data and label templates
Familiarity with harmonized and recognized test standards for labeling
Experience using barcoding systems (e.g. GS1, HIBC-128)
Proficient in label design and management software (e.g. BarTender, GSI Data Hub)
High attention to detail, organization, and accuracy
Instinctual capability for creative thinking and proposing novel solutions
Strong ability to communicate (written and verbally) within and across disciplines and organization structures.
Demonstrated use of quality tools and methodologies (e.g. nonconformance, CAPAs, root cause analysis, etc..).
Experience with Product Lifecycle Management (PLM) software (e.g Windchill, Agile, Propel)
Experience with Enterprise Resource Planning (ERP) software (e.g. Epicor, Net Suite)
Intermediate to advanced proficiency with MS Office Suit (Word, Excel, PowerPoint, Project, Outlook).

Preferred:

Global experience preferred

Salary range: $70,000 to $100,000 per year depending on skills and experience

Benefits

Health Care Plan (Medical, Dental & Vision)
Retirement Plan with Company Match
Paid Time Off, Personal Days, AND Birthday Holiday!
Lifetime Membership Subsidy and Wellness Resources
Life Insurance (Basic, Voluntary & AD&D)
Family Leave (Maternity, Paternity)
Short-Term & Long-Term Disability
Taco Thursdays!!!

Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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About the Company

Nextern

Designs and manufactures medical devices

Nextern designs and manufactures medical devices for equipment makers, with engineering and factory teams involved from early prototypes through production. Its work includes catheter-based instruments and electronic systems used in minimally invasive treatment and diagnostic procedures. Customers pay for development and contract manufacturing services, with project costs shaped by device complexity, materials and production scale. Its clinical markets include vascular and heart interventions and nerve stimulation, with services sold separately or as an integrated program. Founded in 2000 with industrial engineering roots, Nextern shifted to medical devices in 2016 and is headquartered in Maple Grove, Minnesota.

Company size: 501-1,000
Company stage: Not listed
Total funding: Not listed
Headquarters: Maple Grove, MN
Founded: 2000

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