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Haemonetics in Penang, Malaysia is seeking a hands-on Component Engineer to sustain production lines and manage component lifecycle. You will review schematics, assist with ECOs, and support manufacturing with test fixtures and QA documentation.
Key tasks include obsolescence monitoring, alternate component qualification, and CAPA-driven improvements, working across global teams and ISO 13485 environments.
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.
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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