Test Engineer III (IVD / Medical Device)
Core
Technical leader for test engineering activities related to medical devices and IVD systems, leading NPI, test technology development, validation strategy, and audit readiness.
Role type
Senior IC test engineering lead (medical devices/IVD)
Builds
Automated test platforms, validation strategies, and test readiness deliverables for medical and IVD programs
Domain
Medical devices / In Vitro Diagnostics (IVD)
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Test architecture, system-level diagnostics, failure analysis, design for testability, automated test platforms, production data analytics, LabVIEW, NI TestStand, Python, C#, database integration, MES integration, ISO 13485, FDA 21 CFR Part 820, IQ/OQ/PQ, process validation, risk management, ISO 14971, CAPA, design/process change control
Preferred skills
Advanced skills in LabVIEW, NI TestStand, Python, C#, database integration, MES integration, automated reporting, 3+ years of medical device or IVD analyzer experience
Technologies
LabVIEW, NI TestStand, Python, C#, MES
Responsibilities
Lead, coach, and guide Test Engineer I and II resources; Define overall test strategy for assigned medical or IVD programs; Serve as SME for IVD analyzer testing including hematology, urinalysis, immunoassay, and molecular diagnostics; Lead FDA, ISO 13485, MDSAP, and customer audit support; Act as technical escalation point for assigned customer programs
Seniority
Senior, hands-on IC with leadership responsibilities
