Senior Software Design Assurance Engineer

Responsibilities

• Provide technical guidance to software teams on IEC 62304, 21 CFR 820, and other global regulations for SaaS and AI-driven products
• Lead compliance and continuous improvement of software development and validation practices for cloud services and data platforms
• Drive pre-market risk management including Software Hazard Analysis (SHA) and design FMEA for AI/ML functionality
• Guide design and test teams on requirements traceability, configuration management, and tool validation
• Review and approve software design control deliverables for cloud-hosted services and data pipelines
• Support post-market activities including software anomalies, model behavior, and CAPA activities
• Author and maintain technical documentation such as Design History Files, SOPs, and protocols

Requirements

• Strong experience in software design assurance for cloud-based, data platform, or API systems in a regulated environment
• Hands-on knowledge of IEC 62304, FDA 21 CFR Part 820, and ISO 13485
• Proficiency in applying design assurance principles across the SDLC (requirements analysis, architecture reviews, integration)
• Experience with software risk management (SHA, design FMEA) for cloud or AI/ML components
• Ability to communicate compliance topics effectively to technical teams and senior leadership
• Bachelor's degree in a technical discipline with 5-8 years experience (or Master's with 2-5 years, or PhD with 0-2 years)

Preferred Qualifications

• AI/ML experience
• ASQ CSQE certification

Benefits

• Comprehensive benefits program
• Career development through in-house learning or tuition reimbursement
• Global growth opportunities