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About the Role

Heartflow is a medical technology company dedicated to advancing the diagnosis and management of coronary artery disease. We are seeking a Senior Systems Engineer to ensure the completeness and quality of system-level design and documentation for our core products. This role involves translating user needs into technical requirements, owning the functional architecture, and collaborating with the R&D team to create a traceable, testable, and sustainable design. Join us in revolutionizing precision heartcare and transforming coronary artery disease management.

Responsibilities

Define system requirements and maintain the functional system architecture, including subsystems, interfaces, and data flows.
Ensure traceability between user needs, requirements, and verification/validation evidence.
Identify and resolve complex technical issues across system boundaries and coordinate dependencies across engineering disciplines.
Own the system-level verification and validation strategy, defining what needs to be verified, at what level, and the evidence required.
Identify, analyze, and mitigate technical and product risks, supporting failure investigations and root cause analysis.
Evaluate and communicate trade-offs involving performance, safety, usability, reliability, scalability, maintainability, schedule, and cost.
Serve as the technical lead and coordinate cross-functional technical efforts across various teams from concept development through post-market surveillance.
Promote and improve systems engineering practices, including requirements management, risk management, and verification planning.
Mentor Systems Engineers as the team scales.

Requirements

Bachelor's, Master's, or Ph.D. degree in Systems Engineering, Computer Science, Biomedical Engineering, or a related field.
8+ years of industry experience in systems engineering or a related engineering role developing complex software-enabled products.
Demonstrated experience defining functional system architectures, requirements, specifications, and interfaces.
Proven ability to integrate multidisciplinary systems, analyze complex technical problems, perform root cause analysis, and drive issues to resolution.
Experience defining system-level verification strategies and reviewing test plans and results for requirement coverage.
Working understanding of product risk management and design controls.
Working knowledge of IEC 62304 and its governance of the medical device software lifecycle.
Ability to make and communicate sound technical recommendations by balancing user needs, safety, performance, reliability, quality, schedule, and cost.
Ability to lead technical discussions, influence decisions, and collaborate effectively across teams.
Strong written and verbal communication skills, including the ability to communicate complex technical concepts clearly.
Experience with requirements management, issue tracking, documentation, or product lifecycle management tools (e.g., Jira, Ketryx).
Familiarity with Python or similar tools for analysis and automation is a plus.
Experience developing FDA-regulated SaMD or medical imaging systems, including contributing to regulatory submissions.
Experience with cardiovascular imaging, CT, CCTA, or clinical software workflows.
Experience with Model-Based Systems Engineering (MBSE), system modeling, or formal architecture methods.
Familiarity with ISO 14971, ISO 13485, or comparable risk and quality management standards.
INCOSE certification (ASEP, CSEP) or demonstrated fluency with INCOSE requirements-writing practices.
Familiarity with FDA premarket cybersecurity guidance and secure product development practices for connected SaMD.

Skills

Systems Engineering
Requirements Management
System Architecture
Verification and Validation (V&V)
Risk Management
Root Cause Analysis
Cross-Functional Leadership
Technical Communication
Jira
Ketryx
Python

Location

San Francisco, CA

Work Type

4+ days in office
Full-time

Experience Level

Senior
8+ years of industry experience

Education Level

Bachelor's degree
Master's degree
Ph.D. degree

Salary/Compensations

$180,000 to $215,000

Benefits

Bonus
Equity

About the Company

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology.
The flagship product is an AI-driven, non-invasive cardiac test called the Heartflow FFRCT Analysis.
Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway.
Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation.
The product is cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 750,000 patients worldwide.

Equal Opportunity

Heartflow is an Equal Opportunity Employer.
We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.