Technical Writer

Job Description :

Pay Range : $115hr - $120hr

• Author and revise IFUs, operator manuals, installation manuals, service manuals, and quick reference guides in accordance with FDA, MDR, and ISO standards.
• Translate complex engineering concepts into clear, concise, and accessible documentation for clinical and technical audiences.
• Collaborate with cross-functional teams (engineering, regulatory, human factors, QA) to gather source material and verify / validate content.
• Maintain version control and traceability of documentation.
• Support risk management and design history file (DHF) documentation as needed.
• Assist in developing templates, style guides, and documentation standards.
• Familiarity with usability testing, risk management, and regulatory documentation (FDA 21 CFR Part 820, ISO 13485).
• Experience with authoring tools (e.g., Adobe FrameMaker, MadCap Flare, Microsoft Word) and content management systems.
• Experience authoring IFU / operator manuals for highly complex medical devices.

Required Skills :