HeartFlow
HeartFlow

49 Heartflow Software Jobs Hiring Near You

Staff Device Quality Engineer

San Francisco, CA · On-site

$84K - $109K/yr

Your core responsibility will be strategic oversight and hands-on leadership of the end-to-end design control process within Heartflow's Software Development Lifecycle (SDLC). You will ensure that ...

Your core responsibility will be strategic oversight and hands-on leadership of the end-to-end design control process within Heartflow's Software Development Lifecycle (SDLC). You will ensure that ...

Senior Software Engineer

San Francisco, CA · On-site

$144K - $190K/yr

Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA ... We are looking for a Senior Software Engineer to join our world-class engineering team. In this ...

Senior Software Engineer

San Francisco, CA · On-site

$144K - $190K/yr

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease. They are seeking a Senior Software Engineer to design and develop cloud-based services and ...

This position plays a key engineering role in realizing HeartFlow's vision of creating a single, comprehensive platform to manage heart disease. As a Senior Software Engineer, you will help design ...

... HeartFlow's systems and test standards. * Mentor the Test Engineer role and contribute to hiring as the team scales. Qualifications * 5-8 years of experience in software test engineering, SDET, or ...

$200K/yr

Will work with key strategic Heartflow accounts to drive growth and adoption of a cCTA and FFRct ... or medical software is highly desired. * Experience with introducing new cardiovascular ...

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HeartFlow Jobs Information

Do workers at HeartFlow get paid breaks?

Yes. Most people get paid breaks.
71% of people say they get paid breaks.
Based on data from 7 people who took the Breakroom Quiz between January 2025 and April 2026.

Does HeartFlow pay people when they’re sick?

Yes. Most people get paid when they’re sick.
86% of people say they would get paid if they were sick but scheduled to work.
Based on data from 7 people who took the Breakroom Quiz between January 2025 and April 2026.

Is the health insurance from HeartFlow affordable enough for their workers?

Most people say the health insurance costs are okay.
100% of people say the health insurance costs are okay
Based on data from 6 people who took the Breakroom Quiz between March 2025 and October 2025.

Do people get paid time off at HeartFlow?

Most people get paid time off work.
80% of people say they get paid time off.
Based on data from 5 people who took the Breakroom Quiz between June 2025 and April 2026.

Do workers at HeartFlow worry about hours?

Most people don’t worry about getting enough hours.
100% of people report they don’t worry about getting enough hours.
Based on data from 6 people who took the Breakroom Quiz between January 2025 and October 2025.

Do HeartFlow workers get to choose the shifts they work?

Some people don’t get to choose which shifts they work.
40% report that they don’t have enough control over which shifts they work.
Based on data from 5 people who took the Breakroom Quiz between January 2025 and June 2025.

How easy is it to get time off at HeartFlow?

Some people find it hard to get time off.
38% of people report it’s hard to get time off.
Based on data from 8 people who took the Breakroom Quiz between January 2025 and April 2026.

Do HeartFlow managers change schedules at the last minute?

Most managers don’t change people’s schedules at the last minute.
100% of people say their manager doesn’t change their shift schedule at the last minute.
Based on data from 6 people who took the Breakroom Quiz between January 2025 and October 2025.

Do jobs at HeartFlow spill into time workers aren’t paid for?

Rarely. The job doesn't usually spill into unpaid time.
17% of people report that their job takes up time that they don’t get paid for.
Based on data from 6 people who took the Breakroom Quiz between January 2025 and October 2025.

How easy is it to take sick days at HeartFlow?

Most people find it easy to take sick days.
100% of people report that it’s easy to take time off if they are sick.
Based on data from 9 people who took the Breakroom Quiz between January 2025 and April 2026.

Do people at HeartFlow feel treated with respect by their managers?

Most people feel treated with respect by their managers.
89% of people say they’re treated with respect by their managers.
Based on data from 9 people who took the Breakroom Quiz between January 2025 and April 2026.

Do people at HeartFlow get to take their breaks without interruption?

Most people get breaks without interruption.
100% of people report that they get to take their breaks without interruption.
Based on data from 10 people who took the Breakroom Quiz between January 2025 and April 2026.

Is it stressful to work at HeartFlow?

Some people feel stressed out here.
67% of people say they often feel stressed out at work.
Based on data from 9 people who took the Breakroom Quiz between January 2025 and April 2026.

Do people at HeartFlow enjoy their jobs?

Only some people enjoy their job.
60% of people report they don’t enjoy their job.
Based on data from 5 people who took the Breakroom Quiz between January 2025 and October 2025.

Do people at HeartFlow recommend working with their team?

Not many people recommend working with their team.
70% of people report that they wouldn’t recommend working with their immediate team to a friend.
Based on data from 10 people who took the Breakroom Quiz between January 2025 and April 2026.

Do people get enough training when they start at HeartFlow?

Most people got enough training when they started.
70% of people report they got enough training when they started working here.
Based on data from 10 people who took the Breakroom Quiz between January 2025 and April 2026.

Do people get support to advance at HeartFlow?

Only some people are given support to advance their career here.
In the last year, 44% of people report not being given support to advance their career here.
Based on data from 9 people who took the Breakroom Quiz between January 2025 and April 2026.

Do people think HeartFlow’s headquarters understands what’s happening where they work?

Most people think headquarters doesn’t understand what’s happening where they work.
70% of people think that this employer’s headquarters or owners don’t have a good understanding of what’s really happening where they work.
Based on data from 10 people who took the Breakroom Quiz between January 2025 and April 2026.

Do workers feel well informed about how HeartFlow is doing?

Only some people feel well informed about how the company is doing.
50% of people feel that they aren’t kept well informed about how the company is doing as a whole.
Based on data from 8 people who took the Breakroom Quiz between January 2025 and April 2026.
What are the most popular categories at Heartflow?
Infographic showing various Software job openings at Heartflow in the United States as of July 2026, with employment types broken down into 100% Full Time. Highlights an 94% Physical, and 6% Remote job distribution.
Staff Device Quality Engineer

Staff Device Quality Engineer

Heartflow

San Francisco, CA • On-site

$84K - $109K/yr

Full-time

Posted 16 days ago


HeartFlow rating

7.8

Company rating: 7.8 out of 10

Based on 10 frontline employees who took The Breakroom Quiz

136th of 245 rated software companies


Job description

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-an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis-provides a color-coded, 3D model of a patient's coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.
Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 500,000 patients worldwide.
As a Staff Device Quality Engineer, you will serve as the senior technical authority for software quality and design excellence across multiple product lines and platform initiatives. In this highly cross-functional, strategic role, you will shape quality engineering practices organization-wide, bridging the gap between rapid Agile development and rigorous medical device regulations, ensuring that our digital health solutions-including Software as a Medical Device (SaMD) and AI/ML-enabled technologies-are safe, secure, and compliant.
Your core responsibility will be strategic oversight and hands-on leadership of the end-to-end design control process within Heartflow's Software Development Lifecycle (SDLC). You will ensure that software architecture, security, and global regulatory requirements are integrated into every release, and will serve as a key decision-maker and escalation point for quality and compliance matters.
Key Responsibilities
Technical Leadership & Strategy
  • Standards Execution: Lead the application and interpretation of evolving global regulatory standards, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45, to daily development activities; actively monitor regulatory landscape changes and proactively update internal practices.
  • SDLC Architecture & Support: Architect and own validation frameworks for AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1) within the Quality Management System (QMS); define framework strategy and scalability roadmap across the QMS.
  • Agile Integration: Define and champion "Compliance at Speed" frameworks across engineering teams, ensuring Agile sprints meet all regulatory rigor and result in high-quality, predictable releases; develop scalable playbooks and mentor senior engineers on quality-by-design practices.
  • Quality Systems Ownership: Drive continuous improvement of the QMS, identifying systemic gaps and leading cross-functional initiatives to address them. Partner with Quality leadership to influence product strategy, roadmap prioritization, and resource planning.

Design Quality & Risk Management
  • Design Reviews: Lead and govern software architecture reviews to ensure the implementation of safety-by-design and privacy-by-design principles across the full product portfolio; establish review criteria and approve outputs.
  • Risk Analysis: Own and govern comprehensive risk management activities, including Hazard Analysis, Fault Tree Analysis (FTA), and Software FMEAs; establish risk management methodology and ensure alignment across all product lines.
  • V&V Strategy & Execution: Define and own the organization-wide Software Verification and Validation (V&V) strategy; develop and govern test strategies, protocols, and reports to ensure product performance, including for novel AI/ML and SaMD modalities.

Execution & Compliance
  • DHF Program Ownership: Define standards for and govern the Design History File (DHF) from concept to commercialization, ensuring all documentation is audit-ready and design transfer is seamless; accountable for DHF completeness and quality across multiple concurrent programs.
  • Audit Leadership: Lead and coordinate the organization during internal and external audits (e.g., FDA, Notified Body, MDSAP) as a primary subject matter expert for software processes; develop audit readiness programs and host regulatory agency interactions.

Cross-Functional Collaboration & Leadership
  • Technical Documentation: Author, review, and approve technical files for global submissions, including FDA (510k/De Novo), PMDA, and EU-MDR; serve as the quality sign-off authority for regulatory submissions.
  • Team Development & Mentorship: Provide technical coaching and quality training to R&D and Product teams to foster a culture of compliance; mentor and develop Senior and mid-level Quality Engineers, and contribute to hiring and capability planning.
  • Thought Leadership: Represent Heartflow's quality and compliance perspective in industry forums, working groups (e.g., IMDRF, FDA Digital Health Center of Excellence engagement), and external partnerships relevant to SaMD and AI/ML regulation.

Skills Needed
  • Strong critical thinking skills and great attention to detail.
  • Ability to work as a self-starter in a fast-paced, adaptive environment.
  • Excellent communication, documentation, and time management skills.
  • Demonstrated ability to influence without authority and drive alignment across engineering, regulatory, and product leadership.
  • Deep expertise in quality systems strategy, including QMS architecture and CAPA program design for SaMD organizations.

Educational Requirements & Work Experience
  • Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field is required.
  • Master's degree in a relevant technical or quality discipline preferred.
  • 10+ years of experience in quality engineering or product development within the medical device industry, including at least 3 years in a senior or lead quality engineering role for SaMD or AI/ML-enabled products.
  • Certifications (Preferred): ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Black Belt.

This position has an estimated base salary of $165,000 - $205,000, bonus, and equity. #LI-IB1; LI-Hybrid
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.
Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.
Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process. Before providing any personal information to outside parties, please verify the following: A) all legitimate Heartflow recruiter email addresses end with "@heartflow.com" and B) the position described is found on our careers site at www.heartflow.com/about/careers/.

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