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6 дней назад

Verification Engineer (Medical Devices)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
China
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
Verification Engineer (Medical Devices) (V&V/testing): Conducting requirement analysis, design verification, and validation for new and updated medical device products with an accent on test planning, instrumentation, and traceability. Focus on configuring test systems, analyzing measurement data, identifying design defects, and maintaining verification records and design history files.

Location: Taicang, Jiang Su, China; onsite

Company

hirify.global develops healthcare and medical device solutions focused on improving patient care and sustaining lives.

What you will do

  • Analyze requirements and review design inputs and specifications for verifiability.
  • Develop verification plans, protocols, test scripts, schedules, and supporting test tools.
  • Configure test systems and execute verification and validation activities for new and updated products.
  • Use measurement and test equipment to identify design defects and document test results.
  • Create defect logs, support defect management, and maintain traceability from design inputs to verification activities.
  • Maintain Design History Files and comply with applicable quality system documentation.

Requirements

  • Bachelor’s or master’s degree in Mechanical Engineering, Electronics Engineering, or an equivalent field.
  • At least 5 years of experience in product verification and validation, electrical module testing, or software and firmware testing.
  • Hands-on experience with data loggers, oscilloscopes, force gauges, load cells, pressure and flow sensors, regulators, calipers, multimeters, thermocouples, and strain gauges.
  • Ability to configure test systems, analyze data, write test reports, work independently, prioritize tasks, and manage multiple activities.
  • Good verbal and written communication skills in Chinese and English are required.
  • Knowledge of FDA Good Documentation Practice and medical device product development processes.

Nice to have

  • Experience with statistical software for data analysis and graphing.
  • Previous experience in medical device development.

Culture & Benefits

  • Work in a mission-driven healthcare environment focused on saving and sustaining lives.
  • Collaborate with system engineers and other development engineers.
  • Operate in a culture emphasizing ownership, trust, collaboration, accountability, and continuous improvement.
  • Complete applicable training and follow quality system requirements.

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