全职 Test Engineer II (IVD - Medical Device) 工作, 薪水, Jabil 公司招聘中 - Ricebowl

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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