Manufacturing Test Engineer

Job Title: Manufacturing Test Engineer (Medical Devices)

Job Summary

We are seeking a Manufacturing Test Engineer to develop, implement, and support test solutions for medical device products in a high-volume manufacturing environment. The role is responsible for test system development, production support, yield improvement, and compliance with medical regulatory requirements to ensure product quality, safety, and reliability.

Key Responsibilities

• Develop, validate, and maintain manufacturing test systems (ICT, FCT, EOL, system-level tests) for medical device products
• Design and debug test hardware including fixtures, jigs, cables, and interfaces
• Develop and maintain test software/scripts (Python, C/C++, LabVIEW, TestStand, proprietary platforms)
• Support NPI (New Product Introduction) with defined test strategies, coverage, and risk-based test planning
• Ensure all test processes comply with medical device regulatory requirements (e.g. ISO 13485, FDA QSR)
• Perform test validation, CPK Analysis, GR&R, and correlation to ensure accuracy, repeatability, and traceability
• Troubleshoot test failures, analyze yield loss, and implement corrective actions using structured problem-solving tools
• Collaborate closely with Program, Quality, Process, and Manufacturing teams on product and test issues
• Drive continuous improvement initiatives to improve yield, reduce false failures, and optimize test cycle time
• Prepare and maintain controlled documentation (test specifications, protocols, reports, work instructions)
• Support manufacturing line during pilot build, ramp-up, mass production, and sustaining
• Participate in audits, CAPA activities, and change management related to test processes
  

Required Qualifications

• Diploma or Bachelor's degree in Electrical/Electronic Engineering, Mechatronics, or related field
• Experience as a Manufacturing Test Engineer in electronics manufacturing
• Strong knowledge of electronic circuits, PCBA testing, and failure analysis
• Hands-on experience with ATE and test equipment (oscilloscope, DMM, power supplies, signal generators)
• Familiarity with ICT, FCT, and system-level testing
• Ability to work in a regulated manufacturing environment
  

Preferred Skills & Experience

• Direct experience with medical device products (diagnostic, monitoring, therapeutic, or laboratory equipment)
• Knowledge of ISO 13485, FDA 21 CFR Part 820, and risk management practices
• Experience with test validation protocols (IQ/OQ/PQ)
• Programming experience in Python, LabVIEW, TestStand
• Understanding of traceability, serialization, and data integrity
• Experience supporting high-volume or regulated production environments
• Exposure to electrical safety and functional compliance testing
  

Personal Attributes

• Detail-oriented with strong documentation discipline
• Strong analytical and root-cause problem-solving skills
• Able to work cross-functionally and communicate effectively
• Comfortable working under audit and compliance-driven environments