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Engineering Jobs in Minneapolis, MN

Labeling Engineer

Karwell Technologies
  • Minneapolis, MN
  • Quick Apply
30+ days ago

Job Description

Job Description:
  • We are seeking a highly skilled and detail-oriented Medical Device Labelling Engineer with experience in onsite leadership and customer coordination to support global medical device programs. The ideal candidate will have 5 10 years of experience in medical device labelling, regulatory compliance (US and EU), and cross-functional project execution.
  • In addition to core labeling engineering responsibilities, this role requires planning, coordination, and leadership of labeling implementation activities at customer sites, serving as a primary point of contact between the customer and offshore labeling teams. The position demands strong regulatory knowledge, project management capabilities, and the ability to work effectively in a multi-stakeholder, fast-paced environment.
Responsibilities:
  • Labeling Engineering & Compliance.
  • Develop, review, and maintain labeling content including Instructions for Use (IFU), packaging labels, product inserts, and electronic labeling.
  • Ensure labeling compliance with global regulations and standards including:
  • FDA (21 CFR Part 801 & 820).
  • EU MDR.
  • ISO 13485, ISO 20417, ISO 15223.
  • Support product development and lifecycle activities by providing expert labeling guidance.
  • Conduct labeling risk assessments and ensure mitigation of use-related risks.
  • Maintain labeling documentation, version control, and design history files as per quality system requirements.
  • Participate in and support audits, inspections, and notified body interactions related to labeling.
  • Onsite Labeling Lead & Project Coordination.
  • Plan, schedule, coordinate, and lead labeling implementation activities for assigned product lines or Operating Units (OU).
  • Develop and manage integrated EU MDR labeling plans, including activities, timelines, risks, dependencies, and opportunities.
  • Ensure readiness of labeling documentation and samples for Notified Body submissions, audits, and deficiency responses within defined timelines.
  • Serve as the primary labeling point of contact between the customer and company, providing interpretation of EU MDR, global regulations, and customer-specific requirements.
  • Track, monitor, and adjust master schedules and priorities to ensure project milestones are achieved.
  • Provide project status reporting, dashboards, and ad-hoc reports to customer and internal stakeholders.
  • Cross-Functional & Stakeholder Collaboration.
  • Collaborate with Regulatory Affairs, Quality, R&D, Operations, Manufacturing, Marketing, Supplier Quality, and Core Team Leads.
  • Coordinate with translation vendors, Technical Communications teams, and offshore labeling teams for final labeling execution.
  • Represent labeling/graphics on change orders (e.g., IFU changes, BOM changes, PSL, packaging changes).
  • Support Notified Body deficiency response drafting in collaboration with offshore teams and other functions.
  • Partner with Manufacturing and Operations to ensure smooth label implementation and resolve technical issues.
  • Establish and maintain working relationships with suppliers and Supplier Quality teams to support label verification activities.
  • Drive customer branding alignment and assess branding impacts on labeling for assigned operating units.
  • Change Management & Governance.
  • Support change order development, including preparation of documents for customer labeling approvers.
  • Assess change requests and manage resource allocation with offshore labeling teams.
  • Review and approve project plans, SOPs, templates, and labeling standards with key stakeholders.
  • Support leadership in analyzing the impact of EU MDR data or regulatory updates on labeling across products and programs.
Requirements:
  • Bachelor's degree in Engineering, Biomedical, Life Sciences, or a related field.
  • 5 10 years of experience in medical device labeling or documentation engineering.
  • Strong working knowledge of:
  • FDA 21 CFR Part 820 & 801.
  • EU MDR.
  • ISO 13485, ISO 20417, ISO 15223.
  • Hands-on experience with PLM systems and document control tools (e.g., Windchill, Agile, SAP).
  • Proven ability to work in customer-facing onsite roles and lead labeling initiatives.
  • Excellent written, verbal, and stakeholder communication skills.
  • Strong organizational skills, attention to detail, and ability to manage multiple priorities.
Preferred Skills:
  • Experience with labeling and graphics tools such as:
  • Loftware, Bartender, P360.
  • Adobe Illustrator, InDesign.
  • Knowledge of UDI (Unique Device Identification) requirements and implementation.
  • Familiarity with electronic labeling (eIFU) platforms.
  • Experience working in an IT services, engineering consulting, or global delivery model (onsite offshore).
  • Exposure to Cardiac Surgery or Class II/III medical devices (preferred).

Numbers & Facts

LocationMinneapolis, MN

Skills

  • Adobe Illustratorunmatched
  • Adobe InDesignunmatched
  • Agile Programming Methodologiesunmatched
  • Bartendingunmatched
  • Bill of Materials (BOM)unmatched
  • Biologyunmatched
  • Biomedical Engineeringunmatched
  • Brand Marketing (Branding)unmatched
  • Calendar Managementunmatched
  • Cardiac Surgeryunmatched
  • Change Managementunmatched
  • Change Order Managementunmatched
  • Change Requests/Ordersunmatched
  • Code of Federal Regulationsunmatched
  • Communication Skillsunmatched
  • Consumer Brandingunmatched
  • Cross-Functionalunmatched
  • Customer Relationsunmatched
  • Detail Orientedunmatched
  • Document Controlunmatched
  • Documentationunmatched
  • Engineering Consultingunmatched
  • FDA (Food and Drug Administration)unmatched
  • Financial Reportingunmatched
  • Graphicsunmatched
  • ISO (International Organization for Standardization)unmatched
  • Information Technology & Information Systemsunmatched
  • Leadershipunmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Manufacturing Operationsunmatched
  • Marketingunmatched
  • Medical Equipmentunmatched
  • Medical Office Administrationunmatched
  • Multitaskingunmatched
  • Offshoringunmatched
  • Organizational Skillsunmatched
  • Presentation/Verbal Skillsunmatched
  • Problem Solving Skillsunmatched
  • Product Developmentunmatched
  • Product Lifecycleunmatched
  • Product Lifecycle Managementunmatched
  • Product Programsunmatched
  • Product Supportunmatched
  • Project Executionunmatched
  • Project Planningunmatched
  • Project/Program Coordinationunmatched
  • Project/Program Managementunmatched
  • Quality System Requirements (QSR)unmatched
  • Regulationsunmatched
  • Regulatory Complianceunmatched
  • Reporting Dashboardsunmatched
  • Research & Development (R&D)unmatched
  • Resource Managementunmatched
  • Risk Analysisunmatched
  • SAPunmatched
  • Source Code/Configuration Management (SCM)unmatched
  • Standard Operating Procedures (SOP)unmatched
  • Vendor/Supplier Relationsunmatched
  • Windchill PLM Softwareunmatched
  • Writing Skillsunmatched

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