Test Engineer II (IVD Medical Device)
Job Summary
Position Summary
Independently develops validates and sustains production test systems for medical and IVD products. Acts as the primary owner for assigned test processes and supports manufacturing transfer validation and regulatory compliance activities.
Key Responsibilities
Test Development
Develop and optimize functional and system-level test solutions.
Design or improve test fixtures test station architecture and measurement methods.
Develop test software and automation scripts.
Review product design for manufacturability and testability.
NPI and Transfer
Lead test readiness activities for assigned NPI programs.
Support customer design reviews and test strategy discussions.
Support site-to-site transfer customer transfer and production release activities.
Complete tester qualification and readiness before production launch.
IVD Technology Support
Support testing and troubleshooting of fluidics optics motion control temperature control sensors and electronic subsystems.
Validate instrument performance against customer and product specifications.
Support reagent dispensing sample handling optical measurement or imaging-related stations when applicable.
Validation and Compliance
Own IQ/OQ/PQ activities for assigned equipment or processes.
Support software validation traceability documentation and validation summary reports.
Support internal audits customer audits and regulatory inspection preparation.
Ensure test processes comply with applicable quality system requirements.
Technical Requirements
Strong knowledge of 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 expectations.
Education and Experience
Bachelor Degree in Electrical Electronics Biomedical Mechatronics or related Engineering.
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.
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Jabil including its subsidiaries is an equal opportunity employer and considers qualified applicants for employment without regard to race color religion national origin sex sexual orientation gender identity age disability genetic information veteran status or any other characteristic protected by law.
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Required Experience:
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About Company
At Jabil we strive to be the most technologically advanced and trusted manufacturing solutions provider.