Principal Software Design Quality Assurance (DQA) Engineer - Urology
Core
Lead DQA project teams to create and review hardware/software systems for medical electrical systems (MES) in the Urology division, ensuring compliance with FDA, IEC 62304, and ISO 13485 standards.
Role type
Principal Software Design Quality Assurance Engineer
Builds
Medical electrical systems (MES) for surgical kidney stone treatment and urology applications
Domain
Medical Devices / Urology / Regulatory Compliance
Required skills
Risk management, Usability engineering, Software safety classification, Threat modeling, Regulatory compliance (FDA/MDR), Documentation creation, Change control management
Preferred skills
Experience with embedded systems, Cybersecurity, Cloud-based software systems
Technologies
PCBA, FPGA, Firmware, IEC 62304, ISO 13485, 21 CFR 820
Responsibilities
Lead DQA project teams to create/update project documentation meeting regulatory requirements; Identify failure modes and risk control opportunities for complex medical systems; Review SW/HW sub-systems and identify risk control measures; Partner with R&D to define risk-based requirements; Own creation/maintenance of risk management and usability documentation; Participate in usability and design validation activities; Create/review software documentation including DV test plans and security risk analysis.
Seniority
Principal, hands-on IC with strategic oversight