Technical Writer - SaMD (Software Engineering-focused)

Artrya is an Australian medical technology company using AI to help clinicians detect and diagnose heart disease faster and more accurately. The Role We are seeking an experienced Engineer to support the design, development, and continuous improvement of our Software as a Medical Device (SaMD) product, and to maintain regulatory-compliant technical documentation. You will work closely with software, cloud, and infrastructure engineers, AI/ML researchers, QA, Regulatory Affairs, and Product Managers to capture technical knowledge, produce documentation, and drive improvement initiatives. Coding is not required, but a solid understanding of software development and SaMD products is essential. Key Responsibilities Documentation Ownership & Authoring of Technical Documentation (E.g. Software design and architecture, UI specifications, User manuals, Software risk assessments) ensuring documentation is accurate, traceable, and compliant with regulatory requirements Support and actively contribute to design controls, software development lifecycle and change management activities Track and manage dependencies between development, testing,



and documentation activities for each software release Assist with audits and implementation of quality tasks related to the software development lifecycle Contribute to quality system and process improvements About You You will have: A degree in Systems or Software Engineering or a related field Experience in medical devices, SaMD, or regulated software environments and familiarity with ISO 13485, FDA 21 CFR Part 820/QMSR, IEC 62304, and ISO 14971 5+ years of technical writing experience, with at least 3 years in a regulated environment Demonstrated understanding of software development concepts including software architecture, version control, cloud infrastructure and CI/CD deployments Strong writing and communication skills and ability to work effectively across engineering, quality, regulatory, and product teams Why Join Artrya? At Artrya, your work will help deliver technology that supports faster diagnosis and treatment of heart disease. We offer competitive salary, flexible and supportive work workplace, professional development opportunities and the chance to make a meaningful impact in healthcare.

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📌 Technical Writer - SaMD (Software Engineering-focused) (Port Phillip City)
🏢 Artrya
📍 Port Phillip City