Test Engineer III (IVD / Medical Device)

About the role

Jabil is looking for a Test Engineer III who acts as the technical leader for test engineering activities on medical devices and IVD systems. The role covers NPI, test technology development, validation strategy, customer engagement, audit readiness and continuous improvement.

Key responsibilities

• Lead, coach and guide Test Engineers I and II, set test standards and training plans, and review technical solutions, validation plans and test readiness deliverables
• Define the test strategy for assigned programs, approve test station design, measurement approach, validation strategy and automation architecture, and evaluate new test technologies
• Serve as subject matter expert for IVD analyzers (hematology, urinalysis, immunoassay, molecular diagnostics, optical detection, fluidics, motion control, robotics) and lead complex failure analysis
• Lead FDA, ISO 13485, MDSAP and customer audit support, approve validation deliverables and review risk assessments, change controls, CAPA actions and validation impact assessments
• Act as technical escalation point for customers, lead customer technical reviews and support RFQ responses, transfer planning and manufacturing readiness

Required profile

• Bachelor's degree in Engineering; advanced degree preferred but not mandatory
• 5 to 8+ years of test engineering experience
• 3+ years of medical device or IVD analyzer experience preferred
• Demonstrated ownership of NPI, validation programs, customer transfer and audit support

Required skills

• Expert knowledge of test architecture, system-level diagnostics, failure analysis, design for testability, automated test platforms and production data analytics
• Preferred: LabVIEW, NI TestStand, Python, C#, database and MES integration, automated reporting
• Knowledge of ISO 13485, FDA 21 CFR Part 820, IQ/OQ/PQ, process validation, ISO 14971, CAPA and change control