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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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