Senior Software Quality Engineer — SaMD & AI Health Tech

Intuitive; Sunnyvale (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Intuitive is seeking a Senior Software Quality Engineer to provide independent quality oversight for SaMD and cloud-connected healthcare software. You will collaborate with engineering, regulatory, and cybersecurity teams to embed quality by design throughout the software lifecycle.

The role emphasizes early risk identification, architecture reviews, testability improvements, and objective quality judgments to ensure compliance with IEC 62304, FDA QSR, and ISO 13485.

Qualifications

• Senior Software Quality Engineer provides independent quality oversight for SaMD, SiMD, Digital Health, AI/ML-enabled products, and cloud-connected healthcare solutions.
• Partners with software and systems engineering, product security, regulatory affairs, and product quality teams to drive quality by design throughout the software development lifecycle.
• Engages early in product development to identify technical risks, influence software quality practices, evaluate architecture decisions, promote testability, and strengthen software delivery processes with objective quality judgment.
• Participates in requirements, architecture, design, verification, cybersecurity, and release readiness reviews as a technical quality partner.
• Possesses strong software engineering knowledge and deep understanding of modern SDLC practices to challenge technical decisions with risk-based assessment.

Responsibilities

• Serve as the Product Quality representative for software-intensive products across the software development lifecycle.
• Partner with software and systems engineering to drive quality-by-design early in development.
• Participate in architecture, design, and technical reviews to identify quality, reliability, and cybersecurity risks before implementation.
• Evaluate software development practices for alignment with engineering and quality principles.
• Promote shift-left quality practices to prevent defects rather than relying solely on downstream verification.
• Assess software lifecycle execution against IEC 62304, FDA Quality System requirements, and ISO 13485.

Skills

Quality leadership

Regulatory compliance

Risk assessment

SDLC expertise

Cybersecurity awareness

AI/ML regulatory considerations

Tools

CI/CD tooling

SBOM management

Threat modeling

Job description

Intuitive is seeking a Senior Software Quality Engineer to provide independent quality oversight for SaMD and cloud-connected healthcare software. You will collaborate with engineering, regulatory, and cybersecurity teams to embed quality by design throughout the software lifecycle.

The role emphasizes early risk identification, architecture reviews, testability improvements, and objective quality judgments to ensure compliance with IEC 62304, FDA QSR, and ISO 13485.