Label Engineering and Compliance Intern

Role Title: Label Engineering and Compliance Intern

Internship Dates Flexible. Please indicate your preference in your application. Summer 2025 only.

Objective: Medical device labeling is incredibly important as it ensures safety, compliance, and user understanding of products. This summer internship project will focus on transforming the way our company communicates essential product information. 

You will help revamp and optimize all product labels and critical documentation across the organization. You will be at the heart of the action, collaborating with multiple departments to align product information, execute brand strategy, and in some cases, create label content.

Specific Tasks and Responsibilities:

• Revamp Product Labels: Take inputs from historical data, marketing, and engineering teams to ensure all labels are up to date with current product specifications and regulatory requirements
• Collaborate Cross-functionally: Work closely with Regulatory Affairs, Quality, Manufacturing-Operations, and Marketing teams to optimize labels for compliance, production, and customer communication. You will gain exposure to medical device quality systems and external international partners.
• Ensure Compliance: Update labels in accordance with FDA, ISO 13485, and other applicable regulatory standards.
• Perform audits: Identify gaps, improve accuracy, and enhance overall functionality.
• Develop training materials: Create clear and concise training documents and guides to help the company adopt new labeling standards and procedures, ensuring smooth integration into the quality system.

Mentorship:

You will be mentored by the Manufacturing Engineering Manager, with additional guidance and feedback from the Regulatory Affairs, Quality, and Operations teams to ensure accurate and compliant label revisions. This provides a 360-degree view of how your work directly impacts products.

Learning Goals:

• Take ownership of a high-impact project that will directly influence the company’s products and operations.
• Gain hands-on experience in the intersection of design, regulatory compliance, and product management within the medical device industry.
• Develop your problem-solving skills by navigating the balance between creative design and strict regulatory standards.
• Learn how to work in a dynamic, cross-functional team environment with experts in manufacturing, quality, and regulatory affairs.

Expected Deliverables:

• A final presentation showcasing the entire label revamp process and outputs.
• Standardized labels with updated templates and documentation to ensure future consistency.

Timeline:

• Duration: 10-12 weeks (Summer Internship)
• Key Milestones:
  • Weeks 1-2: Onboarding, understanding current labeling processes, and gathering inputs.
  • Weeks 3-4: Begin revising existing labels based on input from cross-functional teams.
  • Weeks 5-8: Continue updates, focusing on regulatory and compliance.
  • Weeks 9-12: Present internship achievements to leadership and coordinate transfer to other engineers. Rolling updates of labels throughout.

Qualifications:

• Detail-oriented with a focus on quality assurance: This is a high-impact, highly regulated area of medical device production.
• Experience with Microsoft Office and design software like Adobe Illustrator, InDesign, or equivalent. Experience with label creation or revision is preferred but not required.
• Understanding or willingness to learn about medical device regulatory requirements, including FDA labeling standards, ISO 13485, and international regulations.
• Strong attention to detail, organizational skills, and the ability to collaborate effectively across departments. Ability to manage multiple tasks and prioritize effectively —comfort working in a fast-paced startup environment.
• Pursuing a degree in Engineering, Design, Life Sciences, Regulatory Affairs, or a related field.
• Familiarity with Adobe Creative Suite or similar design tools.