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3 дня назад

Test Engineer II (Medical Devices)

84 800 - 127 200$
Формат работы
onsite
Тип работы
fulltime
Грейд
middle
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
Test Engineer II (Medical Devices) (Verification and Validation/Automated Testing): Developing and executing automated and manual verification and validation solutions for software and system-level medical device products with an accent on test strategy, regulatory compliance, and product reliability. Focus on creating test frameworks and infrastructure, analyzing defects and root causes, and validating complex products against medical device standards.

Location: Onsite in Lafayette, Colorado, United States; travel is expected approximately 10–20% of the time.

Salary: $84,800–$127,200 USD annually, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies and medical devices across neuroscience, cranial, spinal, navigation, robotics, imaging, and data-driven care solutions.

What you will do

  • Develop verification and validation strategies, test plans, protocols, and reports for software and system-level medical device products.
  • Design, implement, execute, and maintain automated and manual test solutions, frameworks, tools, fixtures, and test infrastructure.
  • Collaborate with engineering, quality, and product development teams to review requirements, designs, usability considerations, risk analyses, and defects.
  • Analyze test results, document findings, recommend corrective actions, and support troubleshooting, debugging, and root-cause investigations.
  • Coordinate internal and external testing activities and maintain test equipment calibration.
  • Improve testing efficiency, product quality, and regulatory compliance.

Requirements

  • Bachelor’s degree in Engineering or Computer Science with 2+ years of relevant experience, or a Master’s degree or PhD.
  • Knowledge of medical device standards and regulations, including AAMI, ISO, FDA, and EN standards.
  • Working knowledge of software design, development, debugging, and testing practices.
  • Experience documenting and executing verification and validation for software or system-level products.
  • Effective written and verbal communication and the ability to collaborate cross-functionally.
  • Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not available for roles below Principal level.

Nice to have

  • Medical device industry experience and knowledge of FDA Quality System Regulations.
  • Experience with automated test frameworks, GUI, integration, and stress testing.
  • Experience with Linux, Cypress, Selenium, JavaScript, C++, Python, Perl, SQL, XML, or continuous integration tools.
  • Knowledge of Agile methodologies, statistical methods, project planning, estimation, tracking, and technical problem solving.

Culture & Benefits

  • Work onsite with cross-functional engineering, quality, and product development teams.
  • Health, dental, and vision insurance, plus health and flexible spending accounts for eligible regular employees.
  • 401(k) plan with employer contribution and match, paid time off, paid holidays, and disability benefits.
  • Tuition assistance, life insurance, employee assistance, stock purchase, and wellness programs.
  • Equal employment opportunity and reasonable workplace accommodations.

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