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Job Details
Role Overview
This is a hands-on technical role focused on sustaining products and production. The successful candidate will:
- Manage electrical component lifecycle, obsolescence, and supplier changes
- Review schematics, PCB layouts, and assembly drawings for manufacturability and compliance
- Support daily production on the Penang production lines, including test fixture maintenance and troubleshooting
- Drive controlled documentation changes and qualifications in line with the Quality Management System
Key Responsibilities
Component Engineering (approximately 50%)
- Manage electrical component lifecycle, including obsolescence monitoring, end-of-life (EOL) notices, and last-time-buy (LTB) analysis
- Identify, evaluate, and qualify alternate components (form, fit, function, and reliability)
- Review suppliers change notifications (SCN) and supplier process notifications (SPN); assess impact and drive implementation at global contract manufacturers
- Create and support engineering change orders (ECOs) with clear technical justification
- Participate in design reviews; review schematics, PCB layouts, assembly drawings, and DFM inputs (design experience preferred, but not required)
- 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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