Senior Verification and Validation Engineer
Core
Lead verification and validation strategy and execution for immunoassay product line, ensuring compliant delivery of diagnostic analyzers for clinical testing.
Role type
Senior Verification and Validation Engineer (Hardware/Software/Lab)
Builds
Diagnostic analyzers and immunoassay systems for hospitals, reference labs, and physician offices
Domain
Life sciences, diagnostics, biotechnology, medical devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
risk-based test planning, complex troubleshooting, requirements traceability, regulated documentation (GDP/ALCOA), cross-functional stakeholder alignment, root-cause analysis, test automation, data analysis/statistics
Preferred skills
Medical device/IVD product development, design controls, risk management (ISO 13485, ISO 14971), integration verification for electro-mechanical systems
Technologies
electro-mechanical systems, embedded software, test automation frameworks
Responsibilities
Lead V&V strategies for moderate-to-high complexity features; drive lab execution on diagnostic analyzers including maintenance and calibration; author and execute V&V protocols and reports; influence cross-functional stakeholders on scope and risk; mentor engineers and improve V&V processes
Seniority
Senior, hands-on IC with technical leadership