Senior CT Imaging Systems Engineer (EID–PCCT)

Socket.dev; San Francisco (CA); On-site; USD 190,000 - 250,000; Full time

Job summary

Heartflow in San Francisco seeks a Staff Systems Engineer specializing in CT imaging to lead system requirements, verification and validation across EID-CT and PCCT. You will partner with Engineering to ensure accurate, consistent results from CT scans across different machines.

Reporting to the Sr. Director of Systems Engineering, you will influence design reviews and regulatory submissions (510(k), De Novo, PMA) and guide cross-functional teams while maintaining traceability and design

Qualifications

• 10+ years of Systems Engineering experience in medical devices or regulated imaging products.
• Direct experience with CT acquisition and reconstruction across EID-CT and PCCT.
• Expertise in statistics and data analyses to quantify imaging performance across variables.
• Ownership of system requirements, traceability, and V&V for regulatory submissions (510(k), De Novo, PMA).
• Familiarity with design controls, quality, risk and software lifecycle in major markets (FDA, EU MDR, PMDA).
• Proficient in written and verbal communication; experience authoring SE documentation for regulatory review.

Responsibilities

• Own the strategy and architecture for optimizing Heartflow CT outputs across scanners and technologies.
• Define CT settings ranges that yield high-quality Heartflow results.
• Collaborate with cross-functional teams on new initiatives leveraging CT tech.
• Design data campaigns with Clinical Research to quantify imaging performance and variance.
• Monitor CT landscape across OEMs and assess impact on Heartflow products.
• Represent Systems Engineering in design reviews and regulatory submissions.
• Maintain full traceability of system requirements from user needs through verification.
• Translate clinical goals into testable, unambiguous requirements.

Skills

Systems Engineering

CT imaging expertise

Statistical analysis

Regulatory submissions

FDA/EU MDR/PMDA knowledge

SaMD development

Cross-functional leadership

Documentation/writing

Education

BS/MS in Systems Engineering / Biomedical Engineering / Physics

Ph.D. preferred

Job description

Heartflow in San Francisco seeks a Staff Systems Engineer specializing in CT imaging to lead system requirements, verification and validation across EID-CT and PCCT. You will partner with Engineering to ensure accurate, consistent results from CT scans across different machines.

Reporting to the Sr. Director of Systems Engineering, you will influence design reviews and regulatory submissions (510(k), De Novo, PMA) and guide cross-functional teams while maintaining traceability and design