Technical Writer (Medical Devices)

Position Overview

We are seeking an experienced Technical Writer to support the CST Technical Communications team in creating and maintaining high-quality documentation for regulated medical devices. The primary focus of this role is authoring and revising Instructions for Use (IFUs) and electronic IFUs (eIFUs) using structured authoring tools and content management systems.

The ideal candidate will have experience with structured XML authoring, medical device documentation, and quality system processes while collaborating with cross-functional teams to deliver documentation that meets regulatory and project requirements.

Key Responsibilities

• Author, update, and maintain Instructions for Use (IFUs) and electronic IFUs (eIFUs) using structured XML (DITA-like) authoring.
• Create and manage technical documentation using Structured FrameMaker and Content Management Systems (CMS).
• Perform change impact/effect analysis for documentation updates.
• Support translation and localization review processes.
• Manage documentation through CMS and quality system publishing workflows.
• Collaborate with Engineering, Regulatory Affairs, Quality Assurance, Software, and Packaging teams to ensure accurate and compliant documentation.
• Research technical information and translate complex concepts into clear, user-friendly documentation.
• Develop and maintain operational manuals, instructional guides, maintenance procedures, and technical publications.
• Ensure all documentation complies with company quality standards and regulatory requirements.
• Support documentation activities throughout the medical device product lifecycle.

Required Qualifications

• Bachelor''''''''s Degree.
• 5+ years of Technical Writing experience.

Required Technical Skills

• Structured content authoring (HTML, XML, DITA, or similar)
• Structured FrameMaker
• Adobe FrameMaker
• Professional publishing tools
• Content Management Systems (CMS)
• IFU (Instructions for Use) development
• Medical device technical documentation
• Quality system documentation processes
• Change effect/impact analysis
• Requirements traceability
• Translation and localization workflows

Preferred Skills

• Adobe Illustrator
• Adobe InDesign
• Adobe Photoshop
• Vasont Content Management System (CMS)
• Experience within the medical device industry or another regulated industry