Test Engineer (IVD / Medical Device)

Jabil Circuit (Singapore) Pte Ltd; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Jabil Circuit (Singapore) Pte Ltd is seeking an experienced Test Engineer to independently develop, validate, and sustain production test systems for medical and IVD products.

You will own test processes, support manufacturing transfers, validation, and regulatory compliance activities, and collaborate with multi-disciplinary teams to ensure product quality and traceability.

Qualifications

• Bachelor’s degree in Electrical, Electronics, Biomedical, Mechatronics or related field.
• 3–5 years of test engineering experience, medical device preferred.
• Experience in validation, NPI, and regulatory readiness (ISO 13485, FDA).

Responsibilities

• Develop and optimize functional and system-level tests for medical devices.
• Lead NPI readiness and transfer activities.
• Support instrument testing across fluidics, optics, motion/temperature control.
• Own IQ/OQ/PQ activities and support audits and compliance.

Skills

Test Engineering

Root Cause Analysis

Statistical Analysis

Test Automation

Documentation & Compliance

Education

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

Tools

LabVIEW

NI TestStand

Python

Visual Basic

SQL

Job description

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.