Sr SW Design Quality Assurance Engineer

Role overview Provide software design assurance for regulated products that rely on cloud services, data platforms, APIs, and AI or machine learning. You will guide engineering and quality practices across product development and maintenance, helping teams manage risk, meet regulatory expectations, and prevent defects. The role works closely with software, test, systems, regulatory, cybersecurity, and product stakeholders.

Responsibilities - Advise development teams on applying software lifecycle and quality requirements to cloud-hosted and data-driven products. - Lead and improve software development and validation practices for distributed services and data platforms. - Prepare and review risk management materials, including hazard analyses, design FMEAs, and risk controls. - Review design controls, traceability, configuration management, tool validation, and integration evidence. - Support post-market investigations into software anomalies, model behavior, data quality, and corrective actions. - Maintain technical records such as design history files, procedures, protocols, and reports; assess proposed infrastructure, data, and model changes.

Requirements - Typically a bachelor’s degree in a technical field and 5–8 years of related experience; a master’s degree with 2–5 years, or a PhD with 0–2 years, may also meet the stated experience profile. - Strong experience in software design assurance for cloud, data platform, API, or service-oriented systems in a regulated setting. - Practical knowledge of IEC 62304, FDA 21 CFR Part 820, ISO 13485, and their application to software products. - Ability to assess software risks, design controls, validation evidence, and changes across a product lifecycle. - Strong communication skills for explaining quality plans, progress, risks, and assurance decisions to cross-functional teams and leaders.

Nice to have - Experience with AI or machine learning systems. - ASQ Certified Software Quality Engineer certification.

Benefits and work setup - Home-office arrangement; hybrid work may be available for people living within commuting distance of a work site.