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8 дней назад

Electrical Engineer (Medical Devices)

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
Malaysia
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Electrical Engineer (Medical Devices): Sustaining electrical components and production fixtures for compliant medical-device manufacturing in Malaysia with an accent on component lifecycle management, manufacturability reviews, and hands-on production support. Focus on qualifying alternate components, troubleshooting electrical test equipment, managing controlled engineering changes, and improving yield and quality across global manufacturing operations.

Location: Batu Kawan, Malaysia; onsite support for Penang production lines, with approximately 10–15% travel as needed

Company

hirify.global develops and manufactures medical devices, with this role supporting compliant production and patient safety.

What you will do

  • Manage electrical component lifecycles, including obsolescence monitoring, end-of-life notices, last-time-buy analysis, alternate-component evaluation, and supply continuity risk mitigation.
  • Review schematics, PCB layouts, assembly drawings, design-for-manufacturability inputs, supplier notifications, and engineering change orders.
  • Provide daily engineering support for Penang production lines and maintain and troubleshoot company-owned electrical test fixtures and production equipment.
  • Perform hands-on electrical debugging using oscilloscopes, function generators, and digital multimeters.
  • Update manufacturing instructions, drawings, and bills of materials through controlled change processes, and plan and execute IQ/OQ/PQ qualifications.
  • Support root-cause analysis, nonconformance investigations, CAPA, yield and process improvements, and technician and operator training while collaborating with R&D, Manufacturing, Quality, Supply Chain, and contract manufacturers.

Requirements

  • Bachelor’s degree in electrical, electronic engineering, or a related field.
  • 3–5 years of experience in electrical, component, or manufacturing engineering.
  • Working knowledge of component lifecycle management, obsolescence, end-of-life, and last-time-buy processes.
  • Proficiency in reading and reviewing schematics, PCB layouts, and assembly drawings.
  • Strong hands-on electrical troubleshooting skills using standard laboratory test equipment.
  • Experience with engineering change orders, supplier change notifications, and controlled documentation; Agile PLM is preferred.
  • Experience with equipment or fixture qualification using IQ/OQ/PQ.
  • Experience working in regulated environments, including ISO 13485; IEC 60601 awareness is required.
  • Experience working with contract manufacturers or EMS providers, plus clear and effective written and verbal English communication.

Nice to have

  • Experience in medical devices or other high-reliability industries such as automotive or aerospace.
  • Knowledge of PCBA manufacturing processes and IPC standards, including IPC-A-610.
  • Familiarity with RoHS and REACH environmental compliance.
  • Exposure to Silicon Expert or similar component lifecycle tools.
  • Knowledge of PFMEA and structured problem-solving methods such as 8D and 5 Whys.
  • Exposure to LabVIEW or automated test systems.
  • Bahasa Malaysia or Mandarin language skills.

Culture & Benefits

  • Hands-on, challenging, and rewarding engineering work in a diverse and dynamic environment.
  • Opportunity to work across global time zones, particularly with Boston-based R&D.
  • Role combines planned component engineering with urgent production support.
  • Work contributes to product quality, patient safety, and the availability of compliant medical devices.

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