About the RoleWe’re seeking a Software Engineer (QA/RA) to help build and support AI/ML-driven medical software. You’ll automate documentation workflows, ensure compliance with medical device standards, and collaborate with QA, regulatory, and engineering teams to deliver high-quality, life-saving technology. Key ResponsibilitiesAutomate QA/RA documentation workflows (Jira, Confluence, GitHub). Ensure compliance with IEC 62304, ISO 13485 and related standards. Build and maintain CI/CD pipelines (e. g. , GitHub Actions). Write structured documentation (Markdown, reStructuredText, LaTeX). Support software verification, validation, and traceability. Collaborate with data science teams on AI/ML compliance.
RequirementsBachelor’s or Master’s in Software Engineering, Computer Science, or similar. 2+ years in software development in a regulated environment. Proficient in Python, Git, and CI/CD pipelines. Experience with QA/RA standards and documentation tools. Strong written and verbal English skills. Nice to HaveExperience with AI/ML software. Knowledge of ISO 14971 (risk management). Familiarity with cloud platforms (e. g. , GCP).
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