rWTRMeKRD rM3stW – Medical Device Documentation — Lafayette, CO

We are seeking an experienced Technical Writer to support a Technical Communication team responsible for medical device documentation. In this role, you will develop and maintain Instructions for Use (IFUs) and electronic IFU (eIFU) content, manage structured content, and support documentation releases within a regulated quality system.

You will collaborate with R&D, Regulatory Affairs, Quality, and software packaging and testing teams to deliver accurate, compliant documentation on project timelines.

Key Responsibilities

• Author, revise, and maintain IFUs and eIFU content using structured XML and DITA-like authoring environments.

• Create and manage documentation using Structured FrameMaker, Oxygen, or comparable professional publishing tools.

• Manage content, revisions, and publishing workflows through a content management system (CMS) and quality system.

• Perform IFU change effect analysis to identify documentation updates required by product or requirements changes.

• Support requirements traceability and documentation review and approval processes.

• Coordinate translation and localization workflows, including content preparation, review, and incorporation of feedback.

• Work with cross-functional partners to resolve documentation issues and support medical device delivery and release activities.

• Manage documentation priorities and deliverables to meet project schedules.

Required Qualifications

• Bachelor’s degree.

• At least 5 years of relevant technical writing experience.

• Experience with Adobe FrameMaker, Structured FrameMaker, or comparable professional publishing tools.

• Ability to author and manage structured content, including XML or HTML.

• Experience with CMS-based content management and structured authoring workflows.

• Familiarity with quality system processes, including change effect analysis, requirements traceability, and translation workflows.

• Strong writing, editing, organizational, and cross-functional communication skills.

• Ability to manage multiple documentation deliverables and meet deadlines.

Preferred Qualifications

• Experience developing medical device IFUs and eIFU content.

• Technical communication experience in medical devices or another regulated industry.

• Experience with Vasont CMS, Oxygen XML Editor, or DITA-based authoring.

• Familiarity with Adobe Illustrator, InDesign, or Photoshop.

• Experience supporting documentation for product releases under regulatory oversight.

Apply

If you have a strong background in structured authoring and enjoy translating complex technical information into clear, accurate user documentation, we encourage you to apply.