Job Overview
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Job Description
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: Bachelor’s degree in Engineering, Technical Communication, Life Sciences, or related field.
5+ years of experience in technical writing, preferably in medical devices or regulated industries.
Strong attention to detail, organization, and ability to manage multiple projects.
Excellent written and verbal communication skills.
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