Description

Our client is a leading innovator in healthcare solutions, focused on delivering connected medical device platforms and mobile applications that improve patient outcomes. This role focuses on developing and enhancing mobile capabilities that enable secure and reliable interaction between patients and connected healthcare products.

Requirements
- Must have
- Excellent written communication skills, with the ability to clearly document complex technical concepts
- Strong technical aptitude and the ability to understand embedded software, system architecture, and design concepts
- Exceptional attention to detail and a commitment to high-quality, accurate documentation
- Strong editing and review skills to identify inconsistencies, ambiguities, gaps, and compliance issues
- Experience with engineering and lifecycle management tools such as Polarion, Helix, Jenkins, Jira, and Confluence
- Good understanding of medical device software development processes and procedures
- Experience creating and maintaining requirements, design documents, traceability artifacts,



verification protocols, test reports, and release documentation
- Understanding of requirements traceability from requirements through design, verification, and release
- Strong cross-functional collaboration skills, working effectively with software, systems, test, quality, and regulatory teams
- Ability to drive document reviews and approvals, and close out review comments
- Strong organizational skills, structuring large volumes of information into clear, maintainable, audit-ready documentation
- Knowledge of FDA Design Controls, IEC 62304, ISO 13485, and DHF documentation

Nice to have
- Experience with AI-assisted documentation and review tools to improve productivity
- Embedded software development experience
- Experience with automated documentation generation and workflow automation
- Systems engineering experience
- Experience automating report generation
- Knowledge of insulin delivery syst

📌 Senior Technical Writer | MUST HAVE: Embedded Software + Medical Applications Experience + Fluent English9 (Buenos Aires)
🏢 Hitachi Vantara
📍 Buenos Aires