Maintain accurate component and BOM documentation in Agile PLM
Support BOM health reviews using Silicon Expert and supply continuity risk mitigation with Supply Chain.
Manufacturing Support (approximately 50%)
Provide day-to-day engineering support for the Penang production lines
Maintain and troubleshoot Haemonetics-owned electrical test fixtures and production equipment, support Clinton, PA fixtures as needed
Perform hands-on electrical debugging using oscilloscopes, function generators, and digital multimeters
Update manufacturing instructions, drawings, and bills of materials through the change control process
Plan and execute fixture and equipment qualifications (IQ/OQ/PQ), including protocols and reports
Support root cause analysis, nonconformance investigations, and corrective and preventive actions (CAPA)
Drive yield, quality, and process improvements; train technicians and operators as needed
Note: This role focuses on sustaining and supporting production fixtures, not on designing new fixtures.
Cross-Functional Collaboration
Partner with R&D, Manufacturing, Quality, Supply Chain, and contract manufacturers
Work effectively across global time zones, especially with Boston-based R&D, travel as needed (approximately 10–15%)
Qualifications
Bachelor’s degree in electrical / Electronic Engineering or related field
3–5 years of experience in electrical, component, or manufacturing engineering, preferably in medical devices or other high-reliability industries (e.g., automotive, aerospace)
Working knowledge of component lifecycle management, obsolescence, EOL, and LTB processes
Proficient in reading and reviewing schematics, PCB layouts, and assembly drawings
Strong hands-on electrical troubleshooting skills using standard lab test equipment
Experience with ECOs, supplier change notifications, and controlled documentation (Agile PLM preferred)
Experience with equipment or fixture qualification (IQ/OQ/PQ)
Experience working in regulated environments (ISO 13485; IEC 60601 awareness)
Experience working with contract manufacturers or EMS providers
Preferred
Knowledge of PCBA manufacturing processes and IPC standards (e.g., IPC-A-610)
Familiarity with environmental compliance (RoHS, REACH)
Exposure to component lifecycle tools (e.g., Silicon Expert or similar)
Knowledge of PFMEA and structured problem-solving methods (e.g., 8D, 5 Whys)
Exposure to LabVIEW or automated test systems
Skills & Competencies
Strong electrical fundamentals 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 balance planned component work with urgent production needs
Ability to work independently and collaboratively in a global organization
Why This Role Matters: Reliable components and stable production lines protect product quality and patient safety. This role is critical to strengthening engineering capability in Malaysia and keeping high-quality, compliant medical devices available to patients worldwide.
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