Technical Writer (User manuals) - Medical Device Job at Infosoft, Inc. in Newton

Technical Writer (User manuals) - Medical Device

We are looking for a Technical Writer/Editor to translate complex technical engineering processes and details into clear, accurate, and compliant documentation for a cutting-edge medical robotics system.

This role involves authoring and revising user manuals, operator manuals, installation manuals, service manuals, and quick reference guides in accordance with FDA, MDR, and ISO standards.

• 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.

Requirements:

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

Nice-to-Have

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

We are an equal opportunity employer and welcome applications from diverse candidates.