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

Job Title: Technical Writer (User manuals) - Medical Device

Pay Rate: $70 to $00/HR

Duration: 12 months

Location: Newton, MA (Hybrid)

Shift: 9:00 AM to 5:00 PM

This position is for the Healthcare Diagnostics division.

We are looking for a Technical Writer/Editor. This role involves translating complex technical engineering processes and details into clear, accurate, and compliant documentation for a cutting-edge medical robotics system. We are a global technology leader in robotic-assisted vascular interventions.

• 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 develop your career with our client:

• 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, Microsoft Word) and content management systems.
• Experience authoring Instructions for Use/operator manuals for highly complex medical devices.

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.