Largeton Group

Development Engineer (IFU content creator / IFU technical writer) Job at Largeto

Largeton Group, Colorado Springs, CO, United States, 80509

2 days ago – Be among the first 25 applicants

This range is provided by Largeton Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range: $50.00/yr - $50.00/yr

Job Summary – Development Engineer (IFU Content Creator / IFU Technical Writer)

C2C

Create, develop, and maintain Instructions for Use (IFU) documents for medical devices, including product illustrations, layout, and content.
Utilize software tools (Bartender, Adobe LiveCycle, EnLabel) to create and revise labeling artwork, ensuring compliance with corporate graphic standards and regulatory requirements.
Manage document control processes using PLM (Windchill) for approval routing and revision control.
Perform prepress activities to prepare accurate labeling artwork files for production.
Proofread labeling artwork with quality tools (e.g., rulers, barcode scanners) to ensure accuracy and adherence to a first-time-right quality standard.
Prepare and route labeling packages for first article inspections and approvals.
Maintain proper documentation, revision control, and storage of all labeling materials.
Collaborate with cross-functional teams (manufacturing, engineering, regulatory, legal, product development, marketing) to complete labeling assignments and resolve issues (NCRs, CAPAs).
Investigate labeling issues, analyze root causes, and implement long-term solutions to improve labeling quality and processes.
Ensure compliance with GMP, FDA, EU MDR, ISO, and company quality system requirements.
Support continuous improvement initiatives in labeling and documentation processes.

Requires a Bachelor's degree (or equivalent experience), proficiency in Adobe Creative Suite and Microsoft Office, and strong attention to detail.
Preferred experience with Adobe LiveCycle, Bartender, EnLabel, Windchill, and knowledge of regulatory standards.
Must possess excellent communication, organizational, and independent judgment skills, and the ability to work with all organizational levels.

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