Technical Writer for Medical Domain

Role Summary

Technical Writer

Key Responsibilities

• Research source material, interview SMEs, gather requirements, and develop high-quality technical content that complies with organizational standards.
• Create, edit, maintain, review, and publish user guides, service manuals, online help systems, knowledge articles, and other technical deliverables across multiple formats.
• Develop content using XML authoring tools and content management systems.
• Track, manage, and resolve documentation defects and improvement opportunities.
• Define documentation methodologies, content frameworks, workflows, and information architecture standards.
• Coordinate reviews, approvals, proofreading, editing, and quality checks to ensure documentation accuracy and completeness.
• Deliver writing projects on schedule and within budget while supporting broader departmental initiatives.
• Create and support graphics, diagrams, illustrations, and visual learning assets for technical content.
• Apply approved AI-assisted authoring tools to improve drafting efficiency, terminology consistency, translation readiness, and content quality while maintaining traceability and human oversight.
• Build and maintain reusable prompt libraries, templates, metadata models, and AI-ready content structures.
• Manage content throughout cloud-based CCMS workflows including authoring, branching, merging, review, approval, publishing, and content migration.
• Document cloud-enabled and AI/ML-powered product capabilities, configurations, connectivity requirements, update management processes, and operational guidance.
• Identify opportunities to automate documentation lifecycle activities including validation, link checking, terminology management, publication workflows, and defect triage.
• Ensure full compliance with organizational policies governing AI usage, information security, privacy, records management, and documentation quality.

Required Qualifications and Technical Skills

Education & Experience

• Associate degree (or equivalent) in Technical Communication, English, Science Writing, Biomedical Engineering, or related discipline, or 6–10+ years of relevant technical writing experience.
• Minimum 5–6 years of professional technical writing experience.
• Proven ability to create, edit, maintain, and manage technical publications throughout the product lifecycle.

Technical Writing Expertise

• Translate complex technical information into clear, concise, and user-friendly documentation.
• Strong understanding of technical writing standards, document structures, terminology management, and content architecture.
• Excellent written, verbal, organizational, project management, and stakeholder communication skills.
• Experience collaborating with cross-functional and global teams.
• Ability to work independently while contributing effectively within a team environment.
• Strong creativity, problem-solving, and content design capabilities.
• Proficiency with XML authoring tools (Oxygen XML), CCMS platforms (Astoria), Adobe FrameMaker, Microsoft Office Suite, Photoshop, and presentation tools.
• Fluent written and spoken English.

AI-Enabled Documentation Capabilities

• Hands-on experience using approved enterprise AI tools (Microsoft 365 Copilot, Claude, ChatGPT Enterprise, or equivalent) for drafting, restructuring, summarization, content reuse, readability improvement, and procedure generation.
• Ability to design, maintain, and optimize reusable prompts and prompt libraries for repeatable documentation workflows.
• Knowledge of AI-assisted language quality tooling, terminology management, machine translation, and machine translation post-editing (MTPE).
• Strong AI content governance skills including fact-checking, hallucination detection, source validation, SME verification, and mandatory human review of AI-generated content.
• Understanding of AI data privacy, security, records-retention, and regulatory requirements, ensuring confidential, customer, PII/PHI, proprietary, and export-controlled data is protected.
• Ability to create structured, metadata-rich, AI-search-optimized content suitable for enterprise search, retrieval-augmented generation (RAG), chatbots, and knowledge assistants.
• Capability to document AI/ML-enabled product features, intended use, limitations, performance characteristics, inputs/outputs, and required human oversight for technical and non-technical audiences.

Cloud Documentation & Digital Content Skills

• Experience working within cloud-hosted authoring platforms, CCMS environments, and cloud publishing pipelines.
• Proficiency with Microsoft 365, SharePoint Online, OneDrive, Teams, and work-tracking platforms such as Azure DevOps, Jira, or ServiceNow.
• Foundational cloud knowledge including SaaS, PaaS, IaaS, multi-tenancy, data residency, identity and access management, SSO, MFA, RBAC, and major cloud platforms (Azure, AWS, or GCP).
• Ability to document cloud-connected workflows including device connectivity, remote monitoring, software updates, licensing, administration, and user management.
• Comfortable working in cloud-first and remote collaboration environments using secure access, version control, and distributed review processes.
• Awareness of cloud security, privacy, and content publication best practices.

Preferred Qualifications

• Experience within medical device, healthcare, industrial, software, or similarly regulated industries.
• Experience developing user manuals, service documentation, online help systems, and XML-based content solutions.
• Understanding of SDLC, DDLC, software development processes, HTML, XML, and related technologies.
• Experience with Docs-as-Code approaches using Git, GitHub, GitLab, Markdown, static site generators, and CI/CD publishing pipelines.
• Knowledge of RAG content design, AI knowledge assistants, metadata schemas, content chunking, and answer-quality evaluation.
• Experience documenting AI/ML-enabled products, Software as a Medical Device (SaMD), cloud services, APIs, integration guides, and developer documentation.
• Familiarity with relevant standards and regulations including ISO 13485, IEC 62304, IEC 82079-1, FDA guidance, EU MDR/IVDR, GDPR, HIPAA, and AI governance frameworks.
• Experience with localization, terminology management, translation memory systems, analytics-driven documentation improvement, and documentation telemetry.
• Cloud, AI, technical communication, or documentation certifications (e.g., AZ-900, AI-900, AWS Cloud Practitioner, STC/tekom certifications).
• Experience creating graphics, illustrations, videos, animations, or digital learning content using modern design tools.