Technical Writing Specialist 2

Roles & Responsibilities

• Develop, write, edit, and maintain customer-facing and internal technical documentation, including:
  • User manuals
  • Installation guides
  • Troubleshooting guides
  • Upgrade/downgrade instructions
  • Instructions for Use (IFUs)
• Ensure documentation complies with regulatory requirements, industry standards, and company policies
• Support documentation for global regulatory submissions
• Create and maintain illustrations, diagrams, flowcharts, line art, and product images
• Collaborate with:
  • Engineering
  • Quality Assurance
  • Regulatory Affairs
  • Clinical/Medical Affairs
  • Marketing & Customer Support
• Review and edit documents for clarity, accuracy, consistency, and compliance
• Develop and enforce documentation standards, best practices, and style guides
• Participate in and drive cross-functional meetings related to documentation timelines and requirements
• Manage multiple documentation projects with competing priorities
• Stay current with regulatory updates, industry trends, and best practices
• Mentor and guide junior technical writers

Experience Required

• 5+ years of experience writing and editing hardware/software technical documentation
• Experience in regulated industries (Medical Devices, Pharmaceuticals, FDA, FCC, DoD, etc.)
• Hands-on experience supporting regulatory compliance and submissions
• Experience with device labeling and packaging content preferred

Skills & Certifications

• Strong technical writing and editing skills
• Expertise in end-user documentation (IFUs, manuals, guides)
• Proficiency in authoring and DTP tools, including:
  • MadCap Flare
  • Adobe FrameMaker
  • Adobe InDesign
  • Adobe Illustrator
• Knowledge of XML / DITA documentation frameworks
• Familiarity with electro-mechanical concepts and software applications
• Strong collaboration and stakeholder communication skills
• Excellent organizational and project management abilities
• Ability to work independently and meet tight deadlines
• Proficiency with Microsoft Word (tracked changes), Acrobat, and editorial markup
• Experience with:
  • Version Control Systems (GitHub, Perforce, SVN, TFS)
  • ERP systems (SAP, Oracle- nice to have)
  • Agile development environments

Eligibilities & qualifications

• Bachelor’s degree or equivalent experience preferred
• Minimum 5 years of relevant technical writing experience
• Strong background in regulatory compliance
• Experience working in large, cross-functional organizations