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Technical Writer/Editor
Technical Writer/EditorThe Judge Group • Newton, MA
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Technical Writer / Editor

Technical Writer / Editor

The Judge Group • Newton, MA
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Our client is currently seeking a Technical Writer / Editor for a 12 month + contract.

Must-Have Skills / Experience

1. Experience writing or leading creation of user guides for complex electromechanical or software-based medical devices.

2. Background in the medical device industry.

3. Ability to work independently.

4. Familiarity with tools such as :

o Adobe FrameMaker

o MadCap Flare

o Microsoft Word

________________________________________

Nice-to-Have

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

________________________________________

Collaboration

  • Will work closely with :

    • o Systems Engineering

    o Product Management

    o Usability Teams

    ________________________________________

    As a Contract Technical Writer, you will be responsible for :

  • 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.

    • This position may suit you best if you are familiar with what is below, and would like to do develop your career :

  • Familiarity with usability testing, risk management, and regulatory documentation (FDA 21 CFR Part 820, ISO 13485).
  • Experience with authoring tools (., Adobe FrameMaker, MadCap Flare, Microsoft Word) and content management systems.
  • Experience authoring IFU / operator manuals for highly complex medical devices.

    • Required skills to have for the success of this role :

  • Bachelor’s degree in Engineering, Technical Communication, Life Sciences, or related field.
  • 8+ 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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    Technical • Newton, MA

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