7 дней назад
Senior Systems Engineer (AI)
180 000 - 215 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Systems Engineer (AI/Medical Technology): Defining system-level architectures, requirements, interfaces, and verification strategies for AI-driven cardiac diagnostic software with an accent on traceability, risk management, and medical device lifecycle compliance. Focus on integrating multidisciplinary systems, resolving complex technical issues, and leading cross-functional engineering efforts across software, algorithms, clinical, regulatory, and quality teams.
Location: San Francisco, California; 4+ days in office
Base salary: $180,000–$215,000 per year, plus bonus and equity.
Company
is a publicly traded medical technology company developing AI-driven, non-invasive cardiac diagnostic solutions for coronary artery disease.
What you will do
- Define system requirements and maintain functional architectures covering subsystems, interfaces, and data flows.
- Maintain traceability between user needs, requirements, and verification and validation evidence.
- Integrate multidisciplinary systems, coordinate engineering dependencies, and resolve complex technical issues.
- Own system-level verification and validation strategy and partner with System Test and Software Engineering teams.
- Identify and mitigate product risks, support root cause investigations, and improve system reliability and performance.
- Lead cross-functional technical efforts and mentor Systems Engineers while improving systems engineering and SDLC practices.
Requirements
- Bachelor’s, Master’s, or Ph.D. degree in Systems Engineering, Computer Science, Biomedical Engineering, or a related field.
- 8+ years of experience in systems engineering or related engineering roles developing complex software-enabled products.
- Experience with functional architectures, requirements, specifications, interfaces, system integration, troubleshooting, and root cause analysis.
- Experience defining system-level verification strategies and working with product risk management and design controls.
- Working knowledge of IEC 62304, including medical device software safety classification and lifecycle documentation.
- Experience with requirements management, issue tracking, documentation, or product lifecycle tools such as Jira or Ketryx.
Nice to have
- Experience with FDA-regulated SaMD, medical imaging, cardiovascular imaging, CT, CCTA, or clinical software workflows.
- Experience with MBSE, system modeling, formal architecture methods, or INCOSE practices and certification.
- Familiarity with ISO 14971, ISO 13485, FDA premarket cybersecurity guidance, SBOMs, or threat modeling.
- Familiarity with Python or similar tools for analysis and automation.
Culture & Benefits
- Work alongside software, algorithm, quality, regulatory, clinical, product, and operations teams.
- Contribute to products used in the diagnosis and management of coronary artery disease.
- Compensation includes base salary, bonus, and equity.
- Equal opportunity workplace committed to a respectful and inclusive environment.
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