Test Engineer (IVD / Medical Device)

Jabil Circuit Sdn Bhd; Singapore; On-site; SGD 89,000 - 156,000; Full time

Job summary

Jabil Circuit Sdn Bhd is seeking a test engineering professional who independently develops, validates, and sustains production test systems for medical and in vitro diagnostic products. You will own assigned test processes and support manufacturing transfer, validation, and regulatory compliance activities.

Key duties include test development, NPI readiness, equipment qualification, and ensuring adherence to ISO 13485 and FDA 21 CFR Part 820 through IQ/OQ/PQ activities and traceability

Qualifications

• Experience with functional and system-level testing.
• Knowledge of test automation tools and scripting.
• Familiarity with ISO 13485 and FDA 21 CFR Part 820 is preferred.

Responsibilities

• 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.
• Lead test readiness activities for assigned NPI programs.
• Support site-to-site transfer, customer transfer, and production release activities.
• Complete tester qualification and readiness before production launch.
• Support testing and troubleshooting of fluidics, optics, motion control, temperature control, sensors, and electronic subsystems.
• Validate instrument performance against customer and product specifications.

Skills

FVT, SLT knowledge

ICT expertise

test fixture design

statistical analysis

root cause analysis

Education

Bachelor Degree in Electrical/Electronics/Biomedical/Mechatronics or related Engineering

Tools

LabVIEW

NI TestStand

Python

Visual Basic

SQL

Job description

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.
• 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.