Technical Writer

Position OverviewWe are seeking a Technical Writer to support our CST Technical Communication team. In this role, you will author, revise, and manage Instructions for Use (IFUs) and electronic IFUs (eIFUs) within a regulated medical device environment. You will work extensively with structured XML authoring tools and component content management systems (CCMS), perform change effect analyses, coordinate localization workflows, and partner with cross-functional teams (R&D, Regulatory, Quality, Software Packaging/Testing) to deliver critical technical documentation on time.Key ResponsibilitiesContent Authoring & Revision: Author and update technical documentation, including IFUs and eIFUs, in structured XML (DITA-like formats).Content Management & Publishing: Manage source content through CMS workflows and the quality system publishing pipeline to ensure seamless releases.Impact & Change Analysis: Perform thorough IFU change effect analysis and requirements traceability to maintain regulatory compliance.Localization Coordination: Support translation and localization review workflows across global regulatory regions.Cross-Functional Collaboration: Partner with R&D, Regulatory Affairs, Quality Assurance, and Software Packaging/Testing teams to support medical device product releases on schedule.Required Qualifications & Top SkillsEducation & ExperienceEducation: Bachelor’s Degree (Technical Writing, English, Communications, Engineering, or a related field).Experience: 5+ years of technical writing experience in a structured, regulated production environment.Top 3 Required Technical SkillsStructured Authoring & CMS: Demonstrated expertise with structured authoring tools (Structured FrameMaker, Oxygen XML Editor, or comparable) and CMS-based content management.Medical Device IFU Development: Proven experience developing technical communications and IFUs within a regulated medical device or life-sciences framework.Quality System Processes: In-depth familiarity with quality system workflows, including change effect analysis, requirements traceability, and translation/localization pipelines.Must-Have SkillsDeep expertise in Adobe FrameMaker (specifically Structured FrameMaker).Strong capability in managing and editing structured markup languages (XML, HTML).Hands-on experience with professional publishing tools and documentation lifecycles.Preferred Qualifications (Nice-To-Have)Experience with Vasont Content Management System (CMS).Proficiency with Adobe Creative Cloud applications (Adobe Illustrator, Adobe InDesign, Adobe Photoshop).Background supporting active medical device releases under strict regulatory oversight.