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Labeling Engineer

Minneapolis, MN, US • Posted 9 days ago • Updated 5 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Project Implementation
Project Management
Regulatory Compliance
Product Development
Risk Assessment
Version Control
System Requirements
Project Coordination
Documentation
Auditing
Status Reports
Dashboard
Regulatory Affairs
Research and Development
Marketing
Translation
Bill Of Materials
PSL
Technical Drafting
Collaboration
Manufacturing
Brand
Change Management
Resource Allocation
Leadership
Biomedicine
Life Sciences
Document Engineering
ISO 13485
ISO 9000
Product Lifecycle Management
Plant Lifecycle Management
Document Management
Windchill
Agile
SAP
Customer Facing
Communication
Organizational Skills
Attention To Detail
Management
Adobe Illustrator
Adobe InDesign
IT Service Management
Global Delivery
Offshoring
Medical Devices

Summary

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.
ssess 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.
dobe 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).

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 93ba8e56b9ef0ce2803672ad3289aded
Posted 9 days ago

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