Position Overview
We 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 Responsibilities
Content 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 Skills
Education & Experience
Education: 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 Skills
Structured 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 Skills
Deep 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.
...Systems Summary of Job Duties Scientific Technician/Technologist (Engineering) Positions Employees in these positions work in direct support of qualified manufacturing, industrial, or mechanical engineering professionals involved in the design, validation,...
Company DescriptionArtech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets...
Chicago, Illinois USA. As the largest independent pump reengineering aftermarket company in the world, Hydro's has provided engineering expertise, pump repair, and support services to the industry since 1969. Job Summary: Responsible for writing original content and ...
...The Aparecio Foundation, NFP is offering an unpaid internship for a Digital Photographer Volunteer for the 100 Women in S.T.E.M. Program. This role requires capturing high-quality images, working with a studio team, and maintaining studio equipment.Ideal candidates are...
job summary: We are seeking a safety-focused and dependable Flight Service Operator (FSO) - Tier 1 to support innovative commercial drone delivery operations across in Montgomery, TX. A current FAA Part 107 Remote Pilot Certificate is required for this position....