Senior Software Design Quality Engineer - AI

# Senior Software Design Quality Engineer - AI

As a highly experienced Senior Design Quality AI Engineer, you will lead design assurance and quality activities for complex software-driven and AI-enabled products. This role requires deep expertise in software development, design quality engineering, and applied artificial intelligence, ensuring products meet the highest standards of safety, performance, compliance, and reliability.

You will act as a strategic technical specialist within the organization, partnering cross-functionally with Engineering, Product Management, Data Science, Cybersecurity, Clinical/Regulatory, and Manufacturing teams to embed quality and compliance throughout the product lifecycle.

## Key Responsibilities

Design Quality Engineering Expertise

• Lead design assurance and quality activities for assigned projects across the full software product lifecycle—from concept to commercialization
• Ensure compliance with design control processes (e.g., ISO 13485, IEC 62304, ISO 14971, IEEE 1633, and AI regulation frameworks such as EU AI Act compliance)
• Act as key partner for defining and maintaining quality strategies and KPIs for complex, multi-component systems integrating software, cloud, data, and AI/ML

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 and 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 specialist during regulatory submissions and audits

Process Excellence & Continuous Improvement

• Mentor teams in quality engineering best practices
• Support development of advanced processes for AI product lifecycle, dataset governance, software traceability, DevOps, and continuous quality monitoring
• Champion culture of "Quality by Design" across R&D