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Labeling Engineer

Karwell Technologies

  • Minneapolis, MN
  • 30+ days ago

    Highlights

    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. Job Description: We are seeking a highly skilled and detail-oriented Medical Device Labeling Engineer with experience in onsite leadership and customer coordination to support global medical device programs.

    Numbers & Facts

    LocationMinneapolis, MN

    Description

    Job Description:
    • We are seeking a highly skilled and detail-oriented Medical Device Labeling 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 labeling, 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.
    Required Qualifications:
    • 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).

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