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Base pay range
$60.00/hr - $63.00/hr
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Overview
The Technical Writer will be responsible for producing accurate, clear, and consistent Instructions for Use (IFU) for robotic medical device systems and instruments. This role involves creating and managing documentation from inception to release, ensuring compliance with FDA and regulatory standards. The position requires collaboration with subject matter experts (SMEs) and cross-functional teams to research, validate, and deliver high-quality technical content.
Key Responsibilities
- Plan, write, and edit IFUs for medical device systems and instruments, including large system manuals, instrument manuals, and ship-with literature using Adobe FrameMaker, Adobe InDesign, and XML.
- Collaborate with SMEs, interaction designers, and technical illustrators to research, validate, and develop content, including raster and vector images.
- Own the document lifecycle from creation to final release, ensuring compliance with FDA and global regulatory requirements.
- Conduct validation and verification of technical documentation, adhering to documentation control processes.
- Act as a representative for technical publications on product development core teams.
- Mentor junior writers and serve as lead writer on assigned projects.
- Participate in regulatory compliance training and proactively raise compliance-related issues to management.
- Collaborate with project team members to share best practices and drive documentation excellence.
Required Skills & Experience
- 5–8 years of technical writing experience in hardware, software, biotechnology, or medical device industries.
- Proven expertise in authoring tools, especially Adobe FrameMaker, Adobe InDesign, and Adobe Acrobat.
- Working knowledge of Adobe Illustrator and Adobe Photoshop (or equivalent).
- Strong writing and grammar skills with the ability to communicate complex technical, scientific, and engineering concepts effectively.
- Excellent verbal communication and interpersonal skills; ability to lead content review meetings and remain calm under pressure.
- Strong organizational and time management skills; ability to prioritize deliverables under tight deadlines.
- Familiarity with XML, DITA, and content management systems preferred.
- Technical troubleshooting skills in FrameMaker, InDesign, and online help software.
- Ability to create error-free PDFs and update or improve document templates.
Education & Training
- Bachelor’s degree in Technical Writing, Communications, English, Professional Writing, or related field (or equivalent experience).
- Certificate in Technical Writing desirable.
Preferred Skills
- Understanding of mechanical concepts and complex mechanical devices.
- Familiarity with the localization process for multilingual documentation.
Seniority level
- Mid-Senior level
Employment type
- Full-time
Industries
- Medical Equipment Manufacturing
- Pharmaceutical Manufacturing
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