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Medical Device Technical Writer

Medical Device Technical Writer

CONFLUX SYSTEMSAuburndale, MA, US
16 hours ago
Job type
  • Full-time
Job description

Job Description

Accepting Candidates from MA, NH, VT, ME

Only W2 / No C2C / No Sponsorship

We are seeking a skilled Technical Writer with experience in the medical device industry to create and manage high-quality documentation for complex electromechanical and software-driven systems. You will translate intricate engineering and clinical concepts into clear, compliant, and user-focused content that meets FDA, MDR, and ISO 13485 standards . This role supports endovascular robotics and requires collaboration with Systems Engineering, Product Management, Usability, and Regulatory teams.

Responsibilities :

  • Author and revise IFUs, operator, installation, service manuals, and quick reference guides.
  • Translate engineering processes into clear documentation for clinical / technical users.
  • Ensure compliance with FDA 21 CFR Part 820, MDR, and ISO 13485 .
  • Collaborate with cross-functional teams for content accuracy and validation.
  • Maintain version control, DHF traceability , and support risk management docs.
  • Develop style guides, templates, and training materials.

Qualifications :

  • Bachelor’s in Engineering, Technical Communication, Life Sciences, or related field.
  • 5+ years of technical writing in medical devices / regulatory industries.
  • Proficiency in Adobe FrameMaker, MadCap Flare, Microsoft Word , and CMS.
  • Strong communication, detail orientation, and ability to work independently.
  • Nice-to-have : experience with robotic systems, training material development, usability testing.
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    Technical Writer • Auburndale, MA, US