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11 часов назад

Principal Systems Verification Engineer (Medical Devices)

112 000 - 154 000$
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
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
Principal Systems Verification Engineer (Medical Devices): Leading system verification and validation for infusion therapy products and laboratory equipment with an accent on regulated testing, traceability, and equipment qualification. Focus on designing verification plans, executing IQ/OQ/PQ activities, automating system testing, and guiding root-cause investigations under FDA and ISO requirements.

Location: Round Lake, Illinois, United States

Salary: $112,000–$154,000 annually, with potential eligibility for discretionary bonuses.

Company

hirify.global develops healthcare products and infusion therapy solutions focused on saving and sustaining lives.

What you will do

  • Lead the planning, development, and execution of system verification deliverables, including test plans, protocols, cases, reports, and studies.
  • Lead validation of laboratory equipment used for infusion system testing, including Infuscale, altitude chambers, and environmental chambers.
  • Develop and execute validation protocols and perform IQ/OQ/PQ activities in alignment with FDA, ISO, and equipment-validation practices.
  • Maintain requirements-to-test traceability and contribute to system requirements, architecture, design, configuration management, and change management.
  • Improve verification processes, automate system testing, and enhance the existing test automation framework.
  • Provide technical leadership, mentor junior engineers, participate in design reviews, and guide investigations into root causes and corrective actions.

Requirements

  • Bachelor’s degree in Mechanical, Electrical, Computer Science, Biomedical Engineering, or a related field.
  • At least 5 years of relevant industry experience.
  • Strong knowledge of ISO, FDA, and other regulatory standards, as well as design controls, lifecycle testing, and MTBF analysis.
  • Strong organization and communication skills, including the ability to work with technical and non-technical stakeholders.
  • Ability to lead teams across multiple sites and influence management with limited assistance.
  • Must be authorized to work for any employer in the United States; visa sponsorship is not available.

Nice to have

  • Medical device industry experience.
  • Experience with test automation.

Culture & Benefits

  • Full-time employment with medical and dental coverage beginning on the first day.
  • Life, accident, disability, and business travel accident insurance.
  • 401(k) retirement plan with company matching and an employee stock purchase plan.
  • Educational assistance, paid holidays, paid time off, family and medical leave, and paid parental leave.
  • Additional commuting, childcare, employee discount, and employee assistance benefits.

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