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