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14 часов назад

Test & Verification Engineer (Medical Devices)

Формат работы
hybrid
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
CR
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
Test & Verification Engineer (Medical Devices): Developing and validating product test methods, verification plans, fixtures, measurement systems, and laboratory processes with an accent on medical-device testing, statistical analysis, and formal validation. Focus on investigating test failures, defining acceptance criteria, maintaining qualified equipment, and supporting audits across product and manufacturing projects.

Location: Prelouc, Czech Republic; hybrid working model with up to 2 days of home office per week. Travel: 10–20% to other facilities, suppliers, and external laboratories.

Company

hirify.global develops and manufactures engineered components, subsystems, and medical devices for healthcare, advanced manufacturing, robotics, minimally invasive surgery, and 3D metal printing.

What you will do

  • Develop test and verification plans for product changes, new products, and validation activities.
  • Execute tests on devices, tube sets, single-use products, and plastic components.
  • Design test fixtures, test rigs, measurement setups, instrumentation, and data-acquisition systems.
  • Define sample sizes and acceptance criteria, analyze test data statistically, and investigate test failures.
  • Develop, document, formally validate, and revalidate product and process test methods.
  • Own the technical readiness, workload prioritization, equipment qualification, maintenance, calibration, and audit support for test rooms and laboratories.

Requirements

  • Bachelor’s degree in Engineering; Mechanical, Manufacturing, Medical, or Materials Engineering is preferred.
  • At least 2 years of test, verification, or manufacturing-support experience with medical devices.
  • Practical experience developing and executing test methods, protocols, and reports.
  • Knowledge of test-method validation, measurement system analysis including Gage R&R, and statistical tools.
  • Knowledge of ISO 13485, ISO 14971, FMEA, 8D, and Six Sigma problem-solving methods.
  • English at B2 level for daily spoken and written communication.

Nice to have

  • CAD experience with SolidWorks.
  • SAP knowledge.

Culture & Benefits

  • Work with an international company developing and manufacturing medical devices.
  • Collaborate on international projects with colleagues across global sites.
  • Flexible working hours and a hybrid work model.
  • 25 days of annual leave and free lunches.
  • Pension savings contribution, Edenred benefits card, transportation allowance, and employee referral bonus.
  • Annual salary review based on performance.

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