Overview As Senior Software Quality Engineer, you provide independent quality oversight for SaMD, SiMD, Digital Health, and AI/ML-enabled cloud healthcare solutions. You partner with engineering, security, regulatory, and quality teams to drive quality by design across the software lifecycle. You'll influence architecture decisions, promote testability, and enforce regulatory and risk-based standards while maintaining objective quality judgment. This role blends hands-on engineering scrutiny with strategic quality leadership to safeguard patient safety and product reliability. You will work in a mission-driven environment that values cross-functional collaboration and continuous improvement.
Compensation / Benefits- market-competitive compensation
- incentives
- benefits
- equity
Responsibilities- Provide independent quality oversight across the software development lifecycle for software-intensive products
- Drive quality-by-design early in product development with software and systems teams
- Participate in architecture, design, and technical reviews to identify quality, reliability, maintainability, and cybersecurity risks
- Ensure lifecycle integrity against IEC 62304, FDA QSR, ISO 13485, and organizational procedures
- Promote shift-left quality practices to prevent defects
- Assess SDLC artifacts, risk controls, traceability, verification, and release evidence
- Review CI/CD pipelines, build management, and release governance for regulatory compliance
- Develop and monitor software quality metrics and guide CAPA and continuous improvement programs
Key requirements- Bachelor's or Master's degree in a technical discipline
- Minimum 8 years of software engineering or quality-related experience
- Hands-on software development and testing experience; familiarity with automation, DevOps, and product development environments
- Ability to review code, architecture, interfaces, and design decisions
- Experience with languages such as C++, Python, C#, Java, JavaScript or similar
- Knowledge of SDLC, regulatory requirements, and quality standards
- Experience with CI/CD tools and modern software configuration management
- Strong communication and ability to challenge technical decisions with objective risk assessment
- collaboration
- analytical thinking
- risk-based decision making
- SDLC expertise (requirements, architecture, design, verification, deployment, maintenance)
- Regulatory and quality standards (IEC 62304, FDA QSR, ISO 13485)
- Cybersecurity in software development and Secure SDLC
