Lead design assurance activities for complex software-driven and AI-enabled products, ensuring highest standards of safety, performance, compliance, and reliability
Job Summary
Lead design assurance activities for complex software-driven and AI-enabled products, ensuring highest standards of safety, performance, compliance, and reliability.
Oversee quality planning, documentation, and reviews for software and AI-enabled solutions, including foundation models and prompt engineering.
Collaborate with R&D teams and conduct expert-level design reviews on architecture, algorithms, code, test strategy, and verification/validation evidence.
Matching Summary
Lead design assurance activities for complex software-driven and AI-enabled products, ensuring highest standards of safety, performance, compliance, and reliability.
Skills & Requirements
Must-have
Design assurance for AI-enabled products
ISO 13485, IEC 62304, ISO 14971 compliance
AI regulation frameworks
Risk management per ISO 14971
AI model validation strategies
Design reviews on architecture and algorithms
Nice-to-have
Champion culture of Quality by Design
Inspire others to prioritize quality
Shift left approach
Key Requirements
15+ years of experience
Bachelor’s (Master’s preferred) degree in Software Engineering, computer science or related field
Experience in New product development, and LCM projects as Design Quality Engineer
Sound understanding of regulatory landscape including ISO13485, ISO14971, IEEE1633, FDA Drugs and cosmetic act (CFRs), IEC62304 and AI
Sound understanding of AI foundation models, prompt engineering, and data processing techniques
Experience with automated testing tools and frameworks