Software Quality Engineering - CoE structure
Core
Senior technical quality leader providing independent oversight for Software as a Medical Device (SaMD), AI/ML-enabled products, and cloud-connected healthcare solutions throughout the software development lifecycle.
Role type
Senior Software Quality Engineer (Technical Quality Partner)
Builds
Independent quality oversight, risk assessments, and process improvements for medical device software and digital health products
Domain
Healthcare / Medical Devices / Digital Health / AI/ML
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Software engineering, SDLC lifecycle management, architecture review, risk assessment, CI/CD pipeline evaluation, automated testing strategy, cybersecurity risk evaluation, regulatory compliance knowledge (IEC 62304, ISO 13485), AI/ML validation principles
Preferred skills
Experience with C++, Python, C#, Java, JavaScript, threat modeling, CAPA investigations, mentorship
Technologies
C++, Python, C#, Java, JavaScript, CI/CD, Agile, DevOps
Responsibilities
Partner with engineering teams to drive quality-by-design; participate in architecture and design reviews to identify technical risks; evaluate software development practices against industry standards; assess CI/CD pipelines and automated quality gates; review verification and validation strategies; evaluate cybersecurity risks and support secure SDLC practices; support quality oversight of AI/ML-enabled solutions; provide technical mentorship to engineering teams
Seniority
Senior, hands-on IC
