Katalyst Healthcares and Lifesciences
Katalyst Healthcares and Lifesciences

Labeling Engineer

Minneapolis, MN, US • Posted 60+ days ago • Updated 9 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

🔗 Matching skills to job...

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
  • Plant Lifecycle Management
  • Product 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 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.
  • 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.
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
  • 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: b332c0938d2ef75f8ab4380553123cd0
  • Posted 30+ days ago
Create job alert
Set job alertNever miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

NPI and Sustaining Systems Engineer, Senior

Saint Paul, Minnesota

•

Today

Full-time

USD 110,000.00 per year

Senior System Design Quality Engineer

Maple Grove, Minnesota

•

Today

Full-time

USD 85,000.00 - 161,500.00 per year

Product Quality Engineer I - Bracco Medical Technologies

Eden Prairie, Minnesota

•

Today

Full-time

USD 79,000.00 - 87,000.00 per year

Medical Device V&V engineers

Remote or New Jersey

•

Today

Full-time

Search all similar jobs
More jobs at Katalyst Healthcares and Lifesciences in Minneapolis, MN