Senior Software Quality Engineer – SaMD & AI/ML

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

Job summary

Intuitive is seeking a Senior Software Quality Engineer in Sunnyvale, CA to lead independent quality oversight across SaMD/SiMD and cloud-connected healthcare solutions. You will partner with software, systems, and security teams to drive quality-by-design throughout the SDLC.

The role emphasizes early involvement in product development, risk-based assessment, and strong engineering practices to meet regulatory and cybersecurity expectations.

Qualifications

• Independent quality oversight across the software lifecycle.
• Experience with architecture reviews and design quality.
• Familiar with regulatory, quality, cybersecurity expectations for medical software.

Responsibilities

• Serve as the Product Quality representative for software-intensive products.
• Drive quality-by-design principles early in product development.
• Evaluate lifecycle against IEC 62304, FDA QSR/ISO 13485 concepts.

Skills

Quality leadership

SaMD quality

Regulatory collaboration

Cybersecurity awareness

Tools

CI/CD tooling

SBOM tooling

Job description

Intuitive is seeking a Senior Software Quality Engineer in Sunnyvale, CA to lead independent quality oversight across SaMD/SiMD and cloud-connected healthcare solutions. You will partner with software, systems, and security teams to drive quality-by-design throughout the SDLC.

The role emphasizes early involvement in product development, risk-based assessment, and strong engineering practices to meet regulatory and cybersecurity expectations.