Title: Technical Writer (Medical Device)
Duration: 6+ Months
Type: W2 contract
Location: Lafayette, CO – Hybrid (3–4 days onsite/week)
Key Responsibilities:
Create, update, and manage medical device Instructions for Use (IFUs) and electronic IFU content using Structured FrameMaker and XML/DITA-based authoring tools.
Manage documentation through Content Management Systems (CMS) and quality-system publishing workflows.
Perform change impact/effect analysis, requirements traceability, and support translation/localization reviews.
Collaborate with R&D, Regulatory Affairs, Quality, and Software teams to ensure compliant and timely documentation releases.
Develop, edit, and maintain technical documentation in accordance with regulatory and quality standards.
Required Skills:
Structured Authoring: Structured FrameMaker, XML/DITA, Oxygen, or similar tools.
Adobe FrameMaker (must-have).
Experience with CMS-based content management and document publishing workflows.
Medical Device or other regulated industry documentation experience.
Knowledge of quality systems, change control, traceability, and translation workflows.
Nice to Have:
Vasont CMS
Adobe Illustrator, InDesign, and Photoshop
Medical Device industry experience.
Education & Experience:
Bachelor’s Degree required.
5+ years of Technical Writing experience, preferably in a regulated environment.