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Labeling Engineer

Minneapolis, MN, US • Posted 10 days ago • Updated 6 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Customer Engagement
Project Management
Risk Assessment
Version Control
Regulatory Compliance
Leadership
Project Coordination
Management
Auditing
Status Reports
Dashboard
Collaboration
Research and Development
Manufacturing Operations
Marketing
Translation
Technical Writing
Bill Of Materials
Manufacturing
Brand
Product Requirements
Change Management
Documentation
Biomedicine
Life Sciences
Medical Devices
Document Engineering
ISO 13485
ISO 9000
Product Lifecycle Management
Plant Lifecycle Management
Document Management
Windchill
Agile
SAP
Customer Facing
Communication
Stakeholder Management
Organizational Skills
Adobe Illustrator
Adobe InDesign
Offshoring
Global Delivery

Summary

Job Description:

We are seeking a highly skilled Medical Device Labeling Engineer with strong expertise in regulatory compliance, labeling development, and cross-functional coordination. This role also involves onsite leadership and customer engagement, serving as a key liaison between client teams and offshore labeling groups.
The ideal candidate will bring deep knowledge of US & EU labeling regulations, strong project management capabilities, and experience working in a fast-paced, multi-stakeholder environment.

Responsibilities:

Labelling Engineering & Compliance:
Develop, review, and maintain labeling content including IFUs, packaging labels, inserts, and e-labeling.
Ensure compliance with global regulations and standards:
- FDA (21 CFR Part 801 & 820)
- EU MDR
- ISO 13485, ISO 20417, ISO 15223
Support product lifecycle activities with labelling expertise.
Conduct labeling risk assessments and mitigation planning.
Maintain labeling documentation, version control, and DHF compliance.
Support audits, inspections, and notified body interactions.

Onsite Leadership & Project Coordination:

Plan, schedule, and lead labeling implementation activities for assigned product lines.
Develop and manage EU MDR labeling plans, including timelines, risks, and dependencies.
Ensure readiness of labeling documentation for submissions, audits, and responses.
ct as the primary point of contact between customer and offshore teams.
Track milestones and provide status reports, dashboards, and updates.

Cross-Functional Collaboration:

Work closely with Regulatory, Quality, R&D, Manufacturing, Operations, and Marketing teams.
Coordinate with translation vendors, technical writing teams, and offshore labeling teams.
Support change management activities (IFU updates, packaging, BOM changes).
ssist in Notified Body deficiency responses.
Partner with Manufacturing to ensure smooth label implementation.
lign labeling with customer branding and product requirements.

Change Management & Governance:

Support change orders and documentation approvals.
Evaluate change requests and coordinate with offshore teams.
Review SOPs, templates, and labeling standards.
nalyze impact of regulatory updates (e.g., EU MDR) across product lines.

Required Qualifications:

Bachelor's degree in engineering, Biomedical, Life Sciences, or related field.
5-10 years of experience in medical device labeling or documentation engineering.
Strong knowledge of:
- FDA 21 CFR Part 801 & 820
- EU MDR
- ISO 13485, ISO 20417, ISO 15223
Experience with PLM/document control systems (Windchill, Agile, SAP, etc.)
Proven experience in customer-facing / onsite roles
Strong communication, stakeholder management, and organizational skills.

Preferred Qualifications:

Experience with labeling/graphics tools: Loftware, Bartender, P360.
Familiarity with Adobe Illustrator, InDesign.
Knowledge of UDI (Unique Device Identification).
Experience with eIFU platforms.
Exposure to Class II/III devices or Cardiac Surgery domain.
Experience working in onsite-offshore/global delivery models.

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: 590a7c797d2b22394877f33e2f571952
Posted 10 days ago

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