Systems Integration Specialist
Core
Integrating component subsystems (hardware, software, assays) into unified diagnostic systems and ensuring end-to-end traceability of functionality and product performance.
Role type
Systems Integration Specialist (IVD/Biologics)
Builds
Automated diagnostic systems, robotic liquid handling platforms, and laboratory instrumentation.
Domain
Healthcare diagnostics, IVDs, Biologics, Medical Devices
Required skills
System integration, verification and validation testing, root cause analysis, statistical data analysis (DOE, Six Sigma), instrument operation and repair, regulatory standards knowledge (IVD/Biologics), cross-functional collaboration
Preferred skills
GLP/GMP knowledge, electromechanical system integration, project management, Python/scripting, Lean Manufacturing, medical device commercialization experience
Technologies
Robotic liquid handling platforms, laboratory instrumentation, Python
Responsibilities
Plan and execute system integration, verification, and validation testing; troubleshoot technical issues involving software, hardware, and robotics; conduct root cause investigations; write and execute test protocols and technical documentation; analyze test data to improve system performance; participate in design reviews; ensure compliance with safety and regulatory standards.
Seniority
Mid-level, hands-on IC
