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2 месяца назад

Senior System Verification Engineer (Medical Devices)

Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Sweden
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

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TL;DR
Senior System Verification Engineer (Medical Devices): Developing and coordinating system-level verification for non-invasive medical scanning devices across the product lifecycle with an accent on regulatory compliance, traceability, and embedded-system testing. Focus on translating IEC 60601, FDA, MDR, and ISO 14971 requirements into robust manual and automated verification strategies, coordinating external test houses, and maintaining compliance through industrialization.

Location: Stockholm, Sweden; hybrid

Company

hirify.global is a Swedish healthcare technology company developing non-invasive medical scanning technology for preventative care and early detection.

What you will do

  • Own system-level verification activities from early concept through industrialization and market release.
  • Partner with hardware, firmware, software, quality, and regulatory teams to ensure medical device compliance.
  • Translate regulatory requirements and standards into testable product requirements and verification strategies.
  • Develop end-to-end, integration, regression, manual, and automated testing methodologies, tools, and workflows.
  • Coordinate specialized testing with external test houses, including EMC, electrical safety, and environmental testing.
  • Create test reports, maintain traceability matrices, communicate findings, and improve verification processes.

Requirements

  • Bachelor’s or Master’s degree in Engineering or a related technical field.
  • 5+ years of system verification and validation experience in a regulated industry, ideally medical devices.
  • Experience testing complex embedded systems across hardware, firmware, and software.
  • Strong familiarity with the IEC 60601 series, especially IEC 60601-1 and IEC 60601-1-2.
  • Familiarity with FDA, MDR, and ISO 14971 regulatory frameworks, plus experience with manual and automated test methods.
  • Good proficiency in English and strong documentation, collaboration, and communication skills.

Culture & Benefits

  • Work in a multidisciplinary engineering environment focused on preventative healthcare.
  • Collaborate across hardware, firmware, software, quality, regulatory, and external partner teams.
  • Contribute to products combining sensors, AI, clinical care, and proprietary scanning technology.

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