Job Description

Technical Writer - SaMD (Software Engineering-focused)

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Artrya is an Australian medical technology company using AI to help clinicians detect and diagnose heart disease faster and more accurately.

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The Role

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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.

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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.

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Key Responsibilities

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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

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Support and actively contribute to design controls, software development lifecycle and change management activities

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Track and manage dependencies between development, testing,



and documentation activities for each software release

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Assist with audits and implementation of quality tasks related to the software development lifecycle

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Contribute to quality system and process improvements

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About You

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You will have:

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A degree in Systems or Software Engineering or a related field

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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

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5+ years of technical writing experience, with at least 3 years in a regulated environment

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Demonstrated understanding of software development concepts including software architecture, version control, cloud infrastructure and CI/CD deployments

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Strong writing and communication skills and ability to work effectively across engineering, quality, regulatory, and product teams

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Why Join Artrya?

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At Artrya, your work will help deliver technology that supports faster diagnosis and treatment of heart disease. We offer market-competitive salary, flexible and supportive work environment, professional development opportunities and the chance to make a meaningful impact in healthcare.

📌 Technical Writer - SaMD (Software Engineering-focused) (Victoria)
🏢 Artrya
📍 Victoria