Technical Writer/Editor

• Contract
• Hybrid

• Bachelor s degree in Engineering, Technical Communication, Life Sciences, or related field.
• 8+ years of experience in technical writing in medical devices or regulated industries.
• Strong attention to detail, organization, and ability to manage multiple projects.
• Excellent written and verbal communication skills.
• Experience writing or leading creation of user guides for complex electromechanical or software-based medical devices.
• Ability to work independently.
• Familiarity with tools such as:
  • Adobe FrameMaker
  • MadCap Flare
  • Microsoft Word

• Experience with robotic systems.
• Experience developing training materials.

• Will work closely with:

• Systems Engineering
• Product Management
• Usability Teams

• Translating complex technical engineering processes and details into clear, accurate, and compliant documentation for a cutting-edge medical robotics system.
• 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, and MS Word) and content management systems.
• Experience authoring IFU/operator manuals for highly complex medical devices.

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