Test Engineer II (IVD / Medical Device)

About the role

Jabil is looking for a Test Engineer II focused on IVD and medical devices. The engineer independently develops, validates and sustains production test systems, owns assigned test processes and supports manufacturing transfer, validation and regulatory compliance.

Key responsibilities

• Develop and optimise functional and system-level test solutions, and design or improve test fixtures, test station architecture and measurement methods
• Develop test software and automation scripts, and review designs for manufacturability and testability
• Lead test readiness for assigned NPI programmes, support design reviews and site-to-site and customer transfers, and complete tester qualification before production launch
• Support testing and troubleshooting of fluidics, optics, motion control, temperature control, sensors and electronics, and validate instrument performance against specifications
• Own IQ/OQ/PQ activities, support software validation and validation reports, and help prepare for internal and customer audits and regulatory inspections
• Ensure test processes comply with quality system requirements

Required profile

• Bachelor's degree in Electrical, Electronics, Biomedical, Mechatronics or a related engineering field
• 3 to 5 years of test engineering experience
• 2+ years of medical device, healthcare or IVD manufacturing experience preferred
• Experience supporting validation and NPI activities

Required skills

• Functional test (FVT), system level test (SLT), ICT, test fixture design, statistical analysis and root cause analysis
• Working knowledge of LabVIEW, NI TestStand, Python, Visual Basic, SQL or other test automation tools
• Practical understanding of ISO 13485, FDA 21 CFR Part 820, equipment validation, CAPA, change control, risk management and DHR