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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