Staff Software Design Quality Engineer
Core
Strategic quality engineering role ensuring compliance, risk management, and process excellence for cloud-based, connected, and software-enabled healthcare solutions.
Role type
Staff Software Design Quality Engineer
Builds
Digital, connected, cloud-based, and software-enabled medical technologies
Domain
Healthcare IT / Medical Devices / Regulatory Compliance
Required skills
Software development lifecycle (SDLC) management, Risk assessment, FMEA, Security risk reviews, Change-impact assessment, Quality system processes, Design control documentation, Audit readiness, Agile/DevOps integration
Preferred skills
SaMD support, FDA regulations, IEC 62304, IEC 82304, Cloud platforms (AWS/Azure/GCP), Mobile technologies (iOS/Android), AI/ML
Technologies
AWS, Azure, GCP, iOS, Android
Responsibilities
Lead software quality and compliance activities for SaaS and medical technologies; Guide product teams through SDLC requirements and design controls; Conduct risk assessments, FMEA, and security reviews; Review quality deliverables for regulatory compliance; Develop quality procedures and governance frameworks; Support audit and inspection readiness; Integrate quality practices into Agile and DevOps environments.
Seniority
Staff, strategic oversight & mentorship