Overview
In this role you lead design quality activities for AI-enabled software products across the full lifecycle. You partner with multidisciplinary teams to embed quality and regulatory compliance, ensuring safety, performance, and reliability. You shape quality strategies, KPIs, and robust verification for software and AI models, including data governance and model explainability. You drive a shift-left culture and collaborate on regulatory submissions and audits. This is an opportunity to impact health tech at scale by elevating AI product quality and compliance.
Verantwoordelijkheden
- Lead design quality activities across the full software product lifecycle from concept to commercialization
- Drive compliance with design control processes (ISO 13485, IEC 62304, ISO 14971, IEEE 1633, AI regulation frameworks)
- Define and maintain quality strategies and KPIs for complex multi-component systems (software, cloud, data, AI/ML)
- 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 validation strategies for AI models including dataset quality, model performance, bias detection, and continuous learning
- Partner with R&D to ensure transparency, explainability, and traceability in AI model development
- Oversee risk management per ISO 14971 (hazard analyses, FMEAs, fault tree analyses, cybersecurity risk assessments, AI-specific risks)
- Evaluate design robustness and reliability using data-driven methods and statistics
- Collaborate with R&D for expert-level design reviews on architecture, algorithms, code, test strategy, and verification/validation evidence
- Identify gaps early and drive cross-functional remediation
- Serve as quality SME during regulatory submissions and audits
- Mentor teams in quality engineering best practices and support advanced processes for AI lifecycle, dataset governance, DevOps, and continuous quality monitoring
- Champion a culture of 'Quality by Design' across R&D
Belangrijkste vereisten
- Bachelor's in Software Engineering, Computer Science or related field with 15+ years of experience
- Experience in new product development and LCM projects as Design Quality Engineer
- Technical skills in C++, C#, Python or similar
- Strong regulatory knowledge: ISO13485, ISO14971, IEEE 1633, FDA Drugs and cosmetics act CFRs, IEC62304 and AI
- Understanding of AI foundation models, prompt engineering, and data processing techniques
- Experience with automated testing tools and frameworks (Selenium, JUnit, PHPUnit)
- Excellent analytical and problem-solving abilities
- Proven ability to lead and mentor teams
- Strong communication skills to convey complex concepts to non-technical stakeholders
- Experience with Agile methodologies and tools
- Knowledge of regulatory standards and software QA/AI compliance
- leadership
- mentorship
- cross-functional collaboration
- AI foundation models
- prompt engineering
- data processing techniques
Senior Software Design Quality Engineer - AI in Nederland werkgever: Jobrapido
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