airegulatory complianceapplied statisticsdicomsystems engineeringmedical devicesverification and validationct imagingphoton counting ct
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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$200к-250к/год
$130к$160кмедиана$190к
По похожим ролям (50) ~ $160к/год
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В Company hidden чётко очерчена техническая лидерская роль на стыке КТ-визуализации, ИИ и регулируемой медицины, с заметной ответственностью и влиянием на разные команды.
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?Редкая специализация
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Описание вакансии
Текст:
Hirify AI/Оригинал
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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