Software Engineer

About the Role

We’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 Responsibilities

• Automate 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.

Requirements

• Bachelor’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 Have

• Experience with AI/ML software.
• Knowledge of ISO 14971 (risk management).
• Familiarity with cloud platforms (e.g., GCP).