Software Engineer, Quality & Process
Core
Ensuring cloud platforms and embedded medical devices meet stringent quality and regulatory standards for organ transplant technologies.
Role type
Senior Software Quality Engineer (Medical Devices)
Builds
Cloud-based medical device platforms and normothermic machine perfusion systems
Domain
Medical device software / Organ transplant technology
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Software Quality Assurance, Regulatory compliance (ISO 13485, FDA, EN 62304, IEC 62366), Software risk management (ISO 14971), Cybersecurity risk management, Cloud solutions architecture, Medical device software lifecycle processes, CI/CD pipeline management, Technical documentation strategy, CAPA management, SOUP validation
Preferred skills
AWS/Azure/GCP experience, IoMT solutions, Python/Java/C#/C++, Programming languages familiarity
Technologies
AWS, Azure, Google Cloud, CI/CD tools, Python, Java, C#, C/C++
Responsibilities
Develop and maintain Software Technical Files and documentation strategies; Execute risk analysis including FMEA and cybersecurity threat modeling; Oversee SOUP and tool validations for QMS compliance; Create and manage test plans, cases, and reports; Drive CAPA activities and process improvements; Act as primary interface between Software, Quality, and Regulatory teams.
Seniority
Senior, hands-on IC
