Overview In this role you will lead independent software quality oversight for SaMD/SiMD, AI/ML-enabled and cloud-connected health solutions, partnering with engineering, regulatory, and security teams to embed quality by design throughout the SDLC. You will influence architecture decisions, promote testability, and ensure regulatory and cybersecurity compliance. You will act as a technical quality authority, guiding verification, validation, and release readiness. This is a chance to shape quality practices across software-intensive products at a global medical device leader.
Compensation / Benefits- market-competitive compensation
- incentives
- benefits
- equity
- accommodation & accessibility support
Responsibilities- Provide independent quality oversight across the software development lifecycle for software-intensive products
- Promote quality-by-design early in product development and participate in architecture/design reviews
- Assess lifecycle compliance against IEC 62304, FDA QSR, ISO 13485, and internal procedures
- Evaluate software development methodologies (Agile, DevOps, CI/CD) for quality and risk
- Review requirements, design specs, risk controls, traceability, verification strategies, and release evidence
- Lead verification/validation strategy with emphasis on automated testing (unit, integration, API, performance)
- Collaborate with Product Security/Cybersecurity to promote Secure SDLC and risk-based validation
- Support AI/ML lifecycle controls, data quality, bias mitigation, and model validation
- Contribute to CAPA, audits, and continuous improvement of software quality processes
- Mentor engineering teams on best practices for software quality and risk management
Key requirements- Bachelor's degree in a technical discipline
- 8+ years in software engineering/quality engineering or related fields
- Strong SDLC knowledge and ability to evaluate architecture and implementation decisions
- Experience with regulatory requirements (IEC 62304, FDA QSR, ISO 13485) and medical device software quality
- Ability to review code, architectures, interfaces, and CI/CD workflows for quality risks
- Experience with C++, Python, C#, Java, JavaScript or similar languages
- Familiarity with DevOps, CI/CD, and automated testing
- Experience with CI/CD tools (Azure DevOps, Jenkins, GitHub Actions, GitLab CI/CD) and SBOM/release governance
- Security-focused software development experience and collaboration with Product Security
- Clear ability to communicate technical risk and influence decisions
- Ability to work across cross-functional teams and maintain independent quality judgment
- collaboration
- critical thinking
- risk-based decision making
- SDLC expertise
- Regulatory compliance knowledge
- Software architecture and design review
