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11 дней назад

Staff Systems Engineer (CT Imaging)

200 000 - 250 000$
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
Staff Systems Engineer (CT Imaging) (Medical Devices/AI): Owning system architecture, requirements, and verification and validation for CT imaging products across EID-CT and PCCT with an accent on scanner variability, reconstruction settings, and imaging performance. Focus on quantifying image-quality variance, translating clinical goals into regulatory-ready requirements, and coordinating CT technology changes across Engineering, Clinical, Regulatory, and Quality.

Location: San Francisco, California

Base salary: $200,000–$250,000, plus bonus and equity.

Company

hirify.global is a publicly traded medical technology company developing AI-driven, non-invasive solutions for diagnosing and managing coronary artery disease, including 3D coronary artery modeling, blood-flow assessment, and plaque analysis.

What you will do

  • Own the system architecture and optimization strategy for hirify.global products across energy-integrating detector CT and photon-counting CT, including scanners, detectors, reconstruction kernels, and imaging techniques.
  • Define acceptable CT scanner and reconstruction settings that produce high-quality hirify.global results and partner with Engineering to address platform differences.
  • Collaborate with Clinical Research to design data campaigns measuring imaging performance and variance across machines, techniques, and patient populations.
  • Monitor CT OEM platforms, vendor roadmaps, market entrants, and technology changes that may affect hirify.global products.
  • Represent Systems Engineering in design reviews, program planning, regulatory submissions, audits, and cross-functional decisions.
  • Maintain requirements traceability, translate clinical and product goals into testable requirements, promote Systems Engineering practices, and mentor Systems Engineers.

Requirements

  • 10+ years of Systems Engineering experience in medical devices and/or regulated imaging products.
  • Direct experience with CT acquisition and reconstruction across both EID-CT and PCCT, including image quality and the effects of machine and technology differences.
  • Expertise in applied statistics and designing analyses that quantify imaging performance, variance, and measurement accuracy across machines, techniques, and patient populations.
  • Experience owning system requirements, traceability, verification and validation, and regulatory submissions such as 510(k), De Novo, or PMA.
  • Working knowledge of design control, quality, risk, and software lifecycle requirements for medical device software across FDA, EU MDR, and PMDA markets.
  • Proficiency in system design, interface definition, requirements writing, and configuration/change control for CT scanners and reconstruction kernels.
  • Experience developing FDA-regulated software as a medical device.
  • Strong written and verbal communication skills, including authoring Systems Engineering documentation suitable for regulatory review.
  • B.S. or M.S. in Systems Engineering, Electrical Engineering, Biomedical Engineering, Physics, or a related discipline; occasional domestic and international travel is required.

Nice to have

  • Ph.D. in a relevant discipline.
  • Deep familiarity with CT scanner platforms and vendor roadmaps; established relationships with CT OEMs.
  • Experience with coronary CT angiography, non-contrast CT, coronary imaging workflows, and AI/ML-enabled clinical decision support.
  • Expertise in DICOM and medical imaging interoperability standards, including IHE, HL7/FHIR, and PACS integration.

Culture & Benefits

  • Work on products intended to improve the diagnosis and management of coronary artery disease.
  • Collaborate across Algorithm, Software, Clinical, Regulatory, Quality, Engineering, and Clinical Research functions.
  • Compensation includes base salary, bonus, and equity.
  • hirify.global supports and respects individuals and maintains an equal opportunity employment policy.

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