Sr Eng, System Verification
Core
Execute system verification and validation (V&V) test procedures for medical devices, specifically infusion pumps, ensuring compliance with regulatory standards and quality requirements.
Role type
Senior System Verification Engineer (Medical Devices)
Builds
Verified medical devices (infusion pumps) ready for regulatory submission and market release
Domain
Healthcare / Medical Device Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
System verification testing, Design Verification activities, Installation/Operational/Performance Qualification protocols, Traceability matrix creation, Regulatory compliance (FDA, IEC, ISO), Test fixture creation, Lab logistics management, Defect investigation, Data analysis (Minitab), JIRA/ALM tools, Risk management, Reliability engineering
Preferred skills
Infusion pump design verification experience
Technologies
Minitab, JIRA, ALM
Responsibilities
Prepare system level test cases and procedures, perform functional and performance testing, lead design verification activities, execute qualification protocols, develop test instructions and protocols, diagnose and investigate defects, support external test houses (EMI/EMC), ensure Good Manufacturing practices, present test findings and evidence
Seniority
Senior, hands-on IC
