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.
Act 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).
Assist in Notified Body deficiency responses.
Partner with Manufacturing to ensure smooth label implementation.
Align 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.
Analyze 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.
Numbers & Facts
Location
Minneapolis, MN
Skills
Adobe Illustratorunmatched
Adobe InDesignunmatched
Analysis Skillsunmatched
Bartendingunmatched
Bill of Materials (BOM)unmatched
Biologyunmatched
Biomedical Engineeringunmatched
Calendar Managementunmatched
Cardiac Surgeryunmatched
Change Managementunmatched
Change Requests/Ordersunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Consumer Brandingunmatched
Cross-Functionalunmatched
Customer Relationsunmatched
Documentationunmatched
FDA (Food and Drug Administration)unmatched
Graphicsunmatched
ISO (International Organization for Standardization)unmatched