Sr Test Engineer (IVD / Medical Device)

Position Summary

Acts as the technical leader for test engineering activities related to medical devices and IVD systems. Leads NPI, test technology development, validation strategy, customer engagement, audit readiness, and continuous improvement initiatives.

Key Responsibilities

Technical Leadership

• Lead, coach, and guide Test Engineer I and II resources.

• Establish test engineering standards, best practices, and training plans.

• Review technical solutions, validation plans, and test readiness deliverables.

• Drive cross-functional problem solving with Manufacturing, Quality, Process, IT, and Customer teams.

Test Architecture Ownership

• Define overall test strategy for assigned medical or IVD programs.

• Approve test station design, measurement approach, validation strategy, and automation architecture.

• Evaluate and implement new test technologies for quality, efficiency, and compliance improvement.

IVD Subject Matter Expertise

• Serve as SME for IVD analyzer testing such as hematology, urinalysis, immunoassay, molecular diagnostics, optical detection, fluidics, motion control, and robotic subsystems.

• Lead complex failure analysis on integrated instrument systems.

• Assess technical gaps during customer transfer and manufacturing readiness reviews.

Regulatory and Audit Leadership

• Lead FDA, ISO 13485, MDSAP, and customer audit support related to test engineering.

• Approve validation deliverables and ensure inspection readiness.

• Review risk assessments, change controls, CAPA actions, and validation impact assessments.

Customer Interface

• Act as technical escalation point for assigned customer programs.

• Lead customer technical reviews and present validation or test performance results.

• Support RFQ responses, transfer planning, and manufacturing readiness strategy.

Technical Requirements

• Expert knowledge of test architecture, system-level diagnostics, failure analysis, design for testability, automated test platforms, and production data analytics.

• Advanced skills in LabVIEW, NI TestStand, Python, C#, database integration, MES integration, and automated reporting preferred.

• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, IQ/OQ/PQ, process validation, risk management, ISO 14971, CAPA, and design/process change control.

Education and Experience

• Bachelor Degree in Engineering; advanced degree is 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