Staff SW Quality Design Engineer
$116,600–$194,400 year
RemoteUnited States
Job Summary
Provide technical guidance to cross-functional teams on IEC 62304, 21 CFR 820, and ISO 13485 standards for cloud-based, data platform, and AI/ML-enabled systems. Lead pre-market risk management deliverables including Software Hazard Analysis, design FMEA, and change control assessments to ensure regulatory compliance. Review and approve software design control deliverables for design history files, protocols, and reports while supporting post-market activities for anomalies and CAPA. Drive continuous improvement of software development and validation practices across distributed systems and data pipelines. Communicate design assurance plans, risks, and progress to senior leadership and engineering stakeholders.
Required Qualifications
- Bachelor's degree in a technical discipline
- Minimum of 8-12 years related experience
- Master's degree and 5-8 years equivalent industry experience
- PhD and 2-4 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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