Sr SW Design Quality Engineer
$95,900–$159,900 year
RemoteUnited States
Job Summary
Provide hands-on technical guidance to cross-functional teams on IEC 62304, 21 CFR 820, and other global regulations for software-as-a-service, data, and AI-driven products. Lead the effective application, compliance, and continuous improvement of software development and validation practices for distributed systems, cloud services, and data platforms. Drive pre-market risk management deliverables, including Software Hazard Analysis, design FMEA, and risk controls related to cloud infrastructure, data processing, and AI/ML functionality. Review and approve software design control deliverables for cloud-hosted services and AI/ML components to ensure regulatory compliance and product quality. Support post-market activities related to software anomalies, model behavior, and CAPA activities. Author, review, and maintain technical documentation including Design History Files and protocols for cloud-based and AI/ML-enabled systems. Assess change control activities to ensure no adverse impact to product performance. Communicate design assurance plans, risks, and considerations to cross-functional teams and senior leadership.
Required Qualifications
- Bachelor's degree in a technical discipline
- Minimum of 5-8 years related experience
- Master's degree and 2-5 years equivalent industry experience
- PhD and 0-2 years experience
Desired Qualifications
- AI/ML experience
- ASQ CSQE certification
- Strong experience in software design assurance for cloud-based, data platform, API, and service-oriented systems in a regulated environment
- Hands-on knowledge of IEC 62304, FDA 21 CFR Part 820, ISO 13485, and their application to software-as-a-service and data-driven products
- Proficiency in applying software design assurance principles across the SDLC, including requirements analysis, architecture and design reviews, implementation oversight, integration, and verification
- Experience performing and reviewing software risk management activities, including Software Hazard Analysis (SHA), design FMEA, and change impact assessments for cloud, data, and AI/ML components
- Skill in reviewing and approving software design control deliverables to ensure traceability, risk control implementation, and regulatory compliance
- Experience supporting software configuration management, tool validation, and integration of cloud services, data pipelines, and platform components
- Ability to communicate effectively with cross-functional partners and clearly present design assurance, risk, and compliance topics to technical teams and senior leadership
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