Labeling Engineer

Katalyst CRO; Minneapolis (MN); On-site; USD 80,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a highly skilled Medical Device Labeling Engineer based in Minneapolis, Minnesota. This position involves developing and maintaining labeling content, ensuring compliance with FDA and EU regulations, and leading labeling implementation activities. The ideal candidate should have a Bachelor's degree in engineering or life sciences, 5-10 years of medical device labeling experience, and strong communication skills. The role emphasizes cross-functional collaboration and project management, making it essential to streamline customer engagement and offshore team coordination.

Qualifications

• 5-10 years of experience in medical device labeling or documentation engineering.
• Deep knowledge of FDA 21 CFR Part 801 & 820, EU MDR, ISO 13485, ISO 20417, ISO 15223.
• Experience with eIFU platforms and Class II/III devices.

Responsibilities

• Develop, review, and maintain labeling content including IFUs and packaging labels.
• Ensure compliance with global regulations and manage labeling documentation.
• Plan, schedule, and lead labeling implementation activities.

Skills

Strong project management capabilities

Customer-facing experience

Stakeholder management

Strong communication skills

Organizational skills

Education

Bachelor's degree in engineering, Biomedical, Life Sciences, or related field

Tools

PLM/document control systems (Windchill, Agile, SAP)

Labeling/graphics tools (Loftware, Bartender, P360)

Adobe Illustrator

InDesign

Job description

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 labeling 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.
• 510 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 onsiteoffshore/global delivery models.