Related skills
powershell python ai iso 13485 fda📋 Description
- Implement design controls for software medical devices per IEC 62304 and FDA
- Lead risk management for software and AI/ML per ISO 14971
- Define and execute verification and validation for software devices, incl AI/ML
- Create and maintain DHFs, risk files, and SOUP management
- Plan, facilitate design reviews for safety, usability, and cybersecurity
- Drive design transfer with DevOps for production
🎯 Requirements
- 5+ years in Software Design Quality Engineering for medical devices
- BSc or MSc in CS, software engineering, biomedical engineering, or equivalent
- Knowledge of IEC 62304, IEC 82304, ISO 14971, ISO 13485, EU MDR/FDA
- Hands-on design controls, risk management, and V&V for software
- DevOps, CI/CD pipelines, and automated testing frameworks
- Python or PowerShell scripting, or willingness to learn
🎁 Benefits
- Dynamic, autonomous work environment
- Growth and development opportunities
- Collaborative, innovative team culture
- Work on SaMD and health software projects
- Exposure to AI/ML-enabled medical devices
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