About this Test Engineer II (IVD / Medical Device) role at Jabil
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.
Accessibility Accommodation
If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to [email protected] with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.#whereyoubelong
