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42 минуты назад

Product Investigator (AI Medtech)

60 000 - 74 780$
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
Product Investigator (AI Medtech): Investigating product accuracy concerns by comparing AI-driven cardiac analyses with Cardiac CTA and producing regulatory-compliant reports with an accent on root cause analysis, clinical documentation, and product quality. Focus on reviewing cardiac imaging findings, identifying process or product deficiencies, recommending corrective actions, and presenting investigation trends to cross-functional teams.

Location: Office-based in Austin, Texas, United States

Salary: $60,000–$74,780 yearly base compensation

Company

hirify.global is a publicly traded medical technology company developing AI-driven, non-invasive solutions for diagnosing and managing coronary artery disease.

What you will do

  • Investigate product accuracy concerns by comparing product features and results with Cardiac CTA images.
  • Review questions and allegations to identify root causes, including potential process, product, and user deficiencies.
  • Prepare detailed written reports with supporting cardiac imaging for clinical review.
  • Support Customer Success and Post-Market Quality teams with customer communications and documentation.
  • Work with Process, Quality, Technology, Training, and Engineering teams to recommend corrective actions.
  • Define and execute projects that improve investigation efficiency, quality, and product accuracy.

Requirements

  • Minimum four years of experience interpreting an imaging modality, preferably Cardiac CTA.
  • Expertise in Cardiac CTA navigation and interpretation is mandatory.
  • Bachelor’s degree in biomedical, industrial, mechanical engineering, another technical field, or equivalent related experience.
  • Experience applying critical thinking and root cause analysis techniques.
  • Strong written and verbal communication, documentation, problem-solving, process development, and task management skills.
  • Experience with Salesforce, quality management systems, Google Suite, DICOM viewers, PowerPoint, and Excel.

Nice to have

  • Experience communicating with physicians, hospital staff, and medical device sales teams.
  • Understanding of FDA regulations, including 21 CFR 820.198, 21 CFR 803, and 21 CFR 806.
  • Root cause analysis experience in the medical device industry.

Culture & Benefits

  • Work in a cross-functional product investigation team supporting customer communication and regulatory compliance.
  • Contribute to improving product accuracy and reducing complaint rates.
  • Work in an environment committed to inclusion, respect, and equal employment opportunity.
  • Support products used by more than 500,000 patients worldwide.

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