Senior Software Quality Engineer - SaMD & AI/ML

SmartRecruiters, Inc.

Sunnyvale (CA)

On-site

USD 150,000 - 216,000

Full time

2 days ago

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Job summary

Intuitive seeks a Senior Software Quality Engineer to provide independent quality oversight for SaMD, SiMD, Digital Health, AI/ML-enabled and cloud-connected healthcare solutions. You will partner with Software Engineering, Regulatory Affairs, and Product Quality teams to drive quality by design across the software lifecycle.

This role engages early in development to identify technical risks, promote testability, influence architecture decisions, and ensure compliance with IEC 62304, FDA QSR,

Qualifications

Independent quality oversight of SaMD/SiMD, Digital Health, AI/ML-enabled and cloud-connected healthcare solutions.
Work with Software Engineering, Regulatory Affairs, and Product Quality to drive quality by design.
Identify technical risks early in development and promote testability across the lifecycle.
Ensure compliance with IEC 62304, FDA QSR, ISO 13485, and cybersecurity standards.

Responsibilities

Provide independent quality consultation and risk assessment.
Participate in requirements, architecture, design, verification, and release readiness reviews.
Review lifecycle artifacts for quality, maintainability, and security considerations.
Promote testability and risk-based decision making in software development.

Skills

Quality leadership

Risk assessment

SDLC expertise

Regulatory knowledge

Education

Bachelor's or Master's in CS/Engineering

Regulatory/compliance knowledge (advantage)

Job description

This role engages early in development to identify technical risks, promote testability, influence architecture decisions, and ensure compliance with IEC 62304, FDA QSR,

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