You are responsible for

Design Quality Engineering Expertise

• Lead Design Quality Engineering activities for assigned projects across the full software product lifecyclefrom concept to commercialization.
• Drive compliance with design control processes (e.g., ISO 13485, IEC 62304, ISO 14971, IEE1633, and AI regulation frameworks such as EU AI Act-ready practices).
• Act as key partner for defining and maintaining quality strategies, KPIs for complex, multi component systems integrating software, cloud, data, and AI/ML in compliance with applicable regulations and standards.
• Software & AI Quality Assurance
• Oversee quality planning, documentation, and reviews for software and AI-enabled solutions (foundation models, prompt engineering).
• Design quality assurance for deep neural networks”, as well as “Governance of training pipelines” (for reproducibility).
• Ensure robust validation strategies for artificial intelligence models, including dataset quality, model performance, bias detection, and continuous learning.
• Partner with R&D teams to ensure transparency, explainability, and traceability in AI model development.
• Risk Management & Compliance
• Oversee risk management activities per ISO 14971, including hazard analyses, FMEAs, fault tree analyses, cybersecurity risk assessments, and AI-specific risks.
• Evaluate design robustness and reliability using data-driven methods and statistical techniques.
• Technical Reviews & Design Assurance
• Collaborate with R&D team and conduct expert-level design reviews on architecture, algorithms, code, test strategy, and verification/validation evidence.
• Identify gaps early in the design and drive cross-functional remediation.
• Serve as a quality SME during regulatory submissions and audits.
• Process Excellence & Continuous Improvement
• Mentor teams in quality engineering best practices.
• Support in developing advanced processes for AI product lifecycle, dataset governance, software traceability, DevOps, and continuous quality monitoring.
• Champion culture of “Quality by Design” across R&D.