Staff Engineer, Design Assurance- Software
Core
Lead software design assurance for safety-critical Class III medical devices, ensuring compliance with FDA and EU regulations across embedded, mobile, and cloud systems.
Role type
Staff Engineer, Software Design Quality
Builds
Cloud Patient Care Networks, mobile applications, and embedded software for heart failure management
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Software development lifecycle, Design control planning, Risk management (ISO 14971), Verification and validation strategy, Regulatory compliance (FDA 21 CFR Part 820, EU MDR), Defect and change control, Audit preparation, Mentoring engineers
Preferred skills
Non-product software validation, Digital toolchain validation, Cross-functional leadership, FMEA execution, Design quality strategy influence
Technologies
Cloud platforms, Mobile applications, Embedded firmware, SaaS platforms
Responsibilities
Plan and lead design control activities ensuring traceability from user needs to release; Review and approve software development plans, requirements, test protocols, and risk files; Lead risk management for software hazards including FMEAs and fault trees; Chair software defect triage and lead CAPA closure; Participate in technical reviews and regulatory inspections; Mentor engineers in design controls and cybersecurity by design.
Seniority
Staff, hands-on IC with strategic oversight
