What are the responsibilities and job description for the Labeling Engineer – Medical Device position at CoreTek Labs?
🚀 Hiring: Labeling Engineer – Medical Device
📍 Minneapolis, MN
🕒 Long Term Contract
👨 💻 8 Years Experience
Looking for experienced professionals with strong expertise in medical device labeling and regulatory compliance.
🔑 Key Skills:
• Medical Device Labeling (IFU, Packaging, eIFU)
• FDA 21 CFR Part 801 & 820
• EU MDR Compliance
• ISO 13485, ISO 20417, ISO 15223
• Labeling Risk Assessment & Documentation
• PLM Tools (Windchill, Agile, SAP)
• UDI Implementation
• Labeling Tools (Loftware, Bartender, P360)
• Adobe Illustrator, InDesign
• Project Management & Onsite Coordination
• Stakeholder Management & Customer Communication
• Change Management & Governance
• Cross-functional Collaboration (RA, QA, R&D, Ops)