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20 часов назад

Senior VAVE Engineer - Systems (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
Senior VAVE Engineer - Systems (Medical Devices): Supporting value analysis and value engineering for IVD and life science instruments manufactured in Suzhou with an accent on systems requirements, design changes, risk management, and verification. Focus on decomposing system requirements, evaluating system impacts, drafting test protocols, and maintaining design history files for complex electro-mechanical products.

Location: Suzhou, Jiangsu, China

Company

hirify.global partners with customers across the globe to develop science and technology solutions for complex challenges.

What you will do

  • Work with the Global R&D team to understand design inputs, design outputs, and other design history file documents.
  • Decompose system requirements into subsystem and module requirements where needed.
  • Provide systems engineering support for value analysis and value engineering activities across products manufactured in Suzhou, including cytometry, centrifuge, particle counting, and liquid handling product lines.
  • Support procurement engineering with design changes by evaluating system impacts, managing risks, and preparing design test protocols.
  • Interpret and test design inputs through characterization, verification, and validation activities.
  • Guide test engineering in drafting test protocols and support successful project execution.

Requirements

  • Bachelor’s degree with 5+ years of experience, master’s degree with 3+ years, or doctoral degree with 0–2 years in engineering or a related field.
  • Systems engineering knowledge in at least one area: dFMEA, risk management, or integration testing.
  • Strong expertise in at least one of mechanical engineering, electronics, or embedded software.
  • Experience in R&D for IVD or medical equipment products.
  • Strong verbal and written communication skills in Mandarin Chinese and English.
  • Ability to work independently and collaboratively while analyzing complex technical problems.

Nice to have

  • Design experience with complex electro-mechanical systems.
  • Experience with IVD and life science instrument systems.
  • Programming and firmware coding experience.
  • Knowledge of automated testing, EMC, product safety standards, ISO 13485, and design control quality systems.
  • Knowledge of IEC 60601 and related product safety requirements.

Culture & Benefits

  • Collaborate with global R&D and procurement engineering teams.
  • Work in a team-oriented environment focused on project success.
  • Contribute to products that support real-world applications of science and technology.

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