Eng II, V&V
Core
Execute system verification testing and design validation activities for medical devices, specifically infusion pumps, ensuring compliance with regulatory standards.
Role type
System Verification Test Engineer (Medical Devices)
Builds
Verified medical devices 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 validation (V&V), Functional and performance testing, IEC basic safety and EMI-EMC standards, Test fixture creation, Lab logistics management, Defect diagnosis and investigation, Traceability matrix preparation, Regulatory compliance (FDA, ISO, IEC), Data analysis (Minitab), Test environment management (ALM, JIRA)
Preferred skills
Infusion pump design verification experience, Risk management, Reliability engineering, Process validation
Technologies
Minitab, JIRA, ALM
Responsibilities
Prepare system level test cases and procedures based on User Requirements Specifications (URS), Execute functional and performance testing, Support Design engineers in building and maintaining test fixtures, Perform Installation/Operational/Performance Qualification Protocols, Diagnose and investigate test defects, Collaborate with external test houses for EMI/EMC testing, Ensure adherence to Good Manufacturing practices and quality systems
Seniority
Mid-Senior, hands-on IC
