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Job Details

Role Overview

This is a hands-on technical role. The successful candidate will:

• Design, develop, verify, validate, and release new electrical test fixtures

• Maintain, troubleshoot, and improve existing fixtures used in production

• Serve as the technical interface to contract manufacturers on their ICT and FCT systems

• Strengthen in-house test capability, including duplicating key contract manufacturer testers on site where needed

Key Responsibilities

Test Fixture Design & Development

• Define test requirements, test strategy, and test coverage for PCBAs and electrical sub-assemblies

• Design test fixture electronics, including schematic capture, PCB layout, and prototype interface boards

• Develop ICT, FCT, and In-System Programming (ISP) test solutions, including fixture hardware, wiring, and instrumentation

• Develop and maintain automated test software using NI LabVIEW (TestStand, Python, or C/C++ where appropriate)

• Apply Design for Manufacturability (DFM) and Design for Test (DFT) principles, review product schematics and PCB layouts for testability

Verification, Validation & Documentation

• Plan and execute fixture verification and validation (IQ/OQ/PQ, test software validation, Gage R&R where required)

• Create clear documentation: test specifications, theory of operation, schematics, work instructions, and troubleshooting guides

• Release fixtures and documentation through Agile PLM using change control (ECOs) in line with ISO 13485 and the Quality Management System

Production & Fixture Sustaining Support

• Maintain and troubleshoot existing fixtures on the Penang production line and support Clinton, PA

• Perform hands-on electrical and mechanical debug using oscilloscopes, function generators, DMMs, power supplies, electronic loads, and DAQ

• Analyze test data and failures, drive root cause analysis, corrective actions, and first-pass yield improvement

• Support fixture calibration, preventive maintenance, spares, and obsolescence planning

• Train and support technicians and operators on fixture use and troubleshooting

Contract Manufacturer & Supplier Interface

• Act as the technical point of contact for contract manufacturer ICT/FCT issues in Malaysia, Australia, and other regions

• Review CM test coverage, programs, and changes, support test-related ECOs and supplier change notifications (SCNs)

• Where needed, duplicate CM testers in-house to support failure analysis and business continuity

Continuous Improvement & Automation

• Improve test reliability, cycle time, and coverage through automation (electrical and mechanical)

• Modernize legacy test systems and standardize fixture design practices across sites

• Support reliability and stress testing fixtures as required

Cross-Functional Collaboration

• Partner with Electrical, Mechanical, Software, Manufacturing, Quality, and Supply Chain teams

• Work effectively across global time zones, especially with Boston-based R&D, travel as needed (approximately 10–15%)

Qualifications

• Bachelor’s or Master’s degree in electrical / Electronic Engineering or related field

• 5–10 years of experience in manufacturing test engineering, preferably in medical devices or other high-reliability industries (e.g., automotive, aerospace)

• Proven ICT and FCT development and debug experience (e.g. Keysight/Agilent 3070, Teradyne Test Station, or similar)

• Strong proficiency in NI LabVIEW for test automation

• Mandatory: hands-on experience designing test fixture PCBs – schematic capture, layout, and prototyping

• Expert-level electrical and mechanical troubleshooting using standard lab test equipment

• Strong ability to read, review, and analyze schematics, PCB layouts, and assembly drawings

• Experience with fixture verification and validation and controlled documentation release (Agile PLM preferred)

• Experience working in regulated environments (ISO 13485; IEC 60601 awareness)

• Experience supporting contract manufacturers and production lines
• NI TestStand; Certified LabVIEW Developer (CLD) or higher

• FPGA development experience

• Python, C/C++, or other instrument-control programming

• Schematic and layout tools such as OrCAD, Altium, or equivalent

• Experience with electromechanical systems (motors, sensors, power supplies)

Skills & Competencies

• Strong technical depth and a hands-on, problem-solving mindset

• Structured and disciplined approach to documentation and quality systems

• Clear and effective communication in English (written and verbal) Bahasa Malaysia or Mandarin is an advantage

• Ability to work independently and collaboratively in a global organization

• Ability to manage multiple priorities across sites and partners

Why This Role Matters: Reliable test fixtures protect product quality and patient safety. This role is critical to building strong test engineering capability in Malaysia and to delivering high-quality, compliant medical devices to patients worldwide.

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