Senior Software (Quality Engineer 4) - 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.
Role type
Senior IC Software Quality Engineer (Medical Device)
Builds
SaMD, SiMD, Digital Health, AI/ML-enabled products, and cloud-connected healthcare solutions
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models
Required skills
Software engineering, SDLC, Architecture review, Risk assessment, CI/CD, Automated testing, Cybersecurity, AI/ML validation, Regulatory compliance (IEC 62304, ISO 13485), Code review
Preferred skills
None stated
Technologies
C++, Python, C#, Java, JavaScript
Responsibilities
Partner with engineering to drive quality-by-design; Participate in architecture and design reviews; Assess CI/CD pipelines and release readiness; Evaluate verification and validation strategies; Support cybersecurity risk assessments; Oversee AI/ML lifecycle controls; Mentor engineering teams on quality practices
Seniority
Senior, hands-on IC