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Senior Software (Quality Engineer 4) - CoE structure

Sunnyvale, CA, us💼 Full-time🗓 2026-09-29 → 2026-09-30

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

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