Medical Device Technical Writer

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.