Labeling Specialist
Nextern
Summary
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.
Job description
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
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
Requirements
- 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)
- Global experience preferred
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Time Off
- Personal Days
- Birthday Holiday
- Lifetime Membership Subsidy
- Wellness Resources
- Life Insurance
- Family Leave
- Short-Term Disability
- Long-Term Disability
- Taco Thursdays
Company overview
Nextern is a collaborative medical device company that specializes in end-to-end medical device product design, development, and manufacturing. Headquartered in Maple Grove, Minnesota, the company operates as a strategic partner for innovators, clinicians, and device companies seeking to accelerate their commercial success. Nextern brings an unmatched core competence in medical device engineering, with expertise spanning from initial concept through full-scale production. The company's capabilities include catheter design, structural heart technologies, neurostimulation systems, wireless connected devices, and surgical robotics. With ISO 13485 certification and FDA registration, Nextern maintains global manufacturing facilities across the United States, Costa Rica, Vietnam, and China, providing flexible production solutions tailored to specific client requirements. The company's unique business model treats clients as collaborators rather than customers, investing in design and development services to build long-term manufacturing partnerships. Nextern's technical expertise covers advanced materials including Nitinol, stainless steel, platinum iridium, and other biocompatible alloys, with specialized capabilities in laser cutting, welding, braiding, and post-processing for complex medical device applications.