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7 дней назад

Senior Software Quality Engineer (CST, AI/MedTech)

103 200 - 154 800$
Формат работы
onsite
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
Senior Software Quality Engineer (AI/MedTech): Supporting the full software development lifecycle for AiBLE surgical planning, navigation, and clinical decision-support technologies with an accent on verification, validation, traceability, and regulatory compliance. Focus on reviewing architecture and risk documentation, maintaining design controls, analyzing quality metrics, and resolving software quality issues in a regulated medical-device environment.

Location: Onsite in Lafayette, Colorado, United States; travel requirements are less than 10%.

Salary: $103,200–$154,800 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies, including connected cranial and spinal solutions designed to improve surgical precision, efficiency, and patient outcomes.

What you will do

  • Lead software quality engineering activities across requirements, design, development, integration, testing, release, and validation.
  • Support the AiBLE portfolio, which applies artificial intelligence, machine learning, and digital technologies to surgical planning, navigation, workflow efficiency, and clinical decision-making.
  • Drive software verification and validation, including traceability, test coverage, and alignment with system and software requirements.
  • Review software architecture, design documentation, risk assessments, and engineering changes for quality and regulatory compliance.
  • Develop and maintain software quality processes, procedures, and standards for compliant product development and commercialization.
  • Analyze quality metrics and partner with cross-functional teams to investigate, resolve, and prevent software quality issues.

Requirements

  • Bachelor’s degree in engineering, computer science, software engineering, or a related technical discipline with 4+ years of software quality engineering experience; alternatively, a master’s degree with 2+ years or a PhD with 0+ years of experience.
  • Experience supporting software verification and validation in a product development environment.
  • Knowledge of software development lifecycle processes, software quality systems, and design control requirements.
  • Experience reviewing requirements, technical documentation, test evidence, risk assessments, and change controls.
  • Ability to collaborate with software, systems, quality, and other cross-functional stakeholders.
  • Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is offered only for Principal-level roles and above.

Nice to have

  • Experience in medical devices or another regulated industry.
  • Knowledge of FDA regulations, IEC 62304, ISO 13485, ISO 14971, and regulatory submission support.
  • Experience with AI-enabled software, Software as a Medical Device, digital health technologies, or embedded software.
  • Experience with test automation, Python, C++, MATLAB, or data-driven testing.

Culture & Benefits

  • Purpose-driven work focused on improving healthcare and patient outcomes.
  • 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 short-term disability coverage.
  • Tuition assistance, life insurance, long-term disability coverage, employee assistance resources, and an employee stock purchase plan.
  • Regular employees may participate in incentive plans and global well-being programs.

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