Software Design Assurance Quality Engineer
Core
Ensures top-level design quality assurance for cloud-based medical software (SaMD, Health IT, EMR) used for medical monitoring, maintaining accuracy and regulatory compliance throughout the software lifecycle.
Role type
Senior IC Software Design Assurance Quality Engineer
Builds
Cloud-based medical software products for Philips Ambulatory Monitoring & Diagnostics
Domain
Medical Device / Health IT / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Software Design Assurance, Software Risk Management (ISO 14971), IEC 62304/82304, SDLC, Agile, Post-market analytics, Design traceability, Design for Quality (DfQ)
Preferred skills
AI Large Language Model (LLM) experience, ISO 9007 environment experience, Agile/SAFe certifications
Technologies
Cloud platforms, Medical Software frameworks
Responsibilities
Lead assessment of software designs by reviewing test and performance data; Conduct root cause analyses for software quality issues; Implement software quality plans and risk management activities; Monitor and report on key software quality metrics; Provide guidance on quality engineering practices and regulatory compliance; Identify opportunities for process improvements in software quality engineering.
Seniority
Senior, hands-on IC