Technical Writer
Core
Produces and maintains controlled documentation for regulated software to ensure traceability and audit readiness for implantable heart failure management devices.
Role type
Technical Writer (Regulated Software)
Builds
Design control artifacts, GMP protocols, test procedures, and user-facing documentation for medical device software.
Domain
Medical Technology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Technical writing, editing, proofreading, GMP protocol creation, document consistency management, cross-functional collaboration, regulatory documentation standards
Preferred skills
Biotechnology or medical device industry experience, Microsoft Office Suite proficiency, Adobe/Photoshop experience, complex project management
Technologies
Microsoft Word, Excel, PowerPoint, Publisher, Adobe, Photoshop
Responsibilities
Create and maintain GMP protocols, reports, and test procedures; Develop controlled documentation for software traceability; Maintain documentation in standard formats; Partner with engineering and quality teams to understand product changes; Review documents for style and clarity; Resolve inconsistencies in content and structure.
Seniority
Mid-level, hands-on IC
