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 FFRCTAnalysis—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 (FFRCTAnalysis), 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.
The Director of Engineering in Test leads the test engineering organization at Heartflow, overseeing the test strategy and execution required to ensure predictable, complete, high quality product releases at scale. We are looking for a candidate in this leadership role that brings deep technical expertise, excellence in test design and planning, verification experience with regulated medical software, past oversight running test organizations, ability to drive team commitment to meet program objectives and timelines, operational rigor, and partner with cross-functional leaders to continually improve quality.
Responsibilities:
- Establish test engineering strategy and quality architecture across all product lines and platforms. Oversee test planning, execution, and quality for product releases.
- Ensure testing activities adhere to company processes and align with regulatory standards (e.g., IEC 62304, ISO 14971, 21 CFR Part 820, FDA guidance).
- Oversee verification of functional and non-functional requirements, including performance, load, and scalability testing, and build and maintain the necessary testing infrastructure.
- Predictable test delivery of platform initiatives, identifying and mitigating project risks, and adapting resource plans and strategies as necessary.
- Establish standards for automated testing, tooling, and test frameworks across all components, including UI, API, services, data pipelines, and ML/AI.
- Guide the creation, management, and validation of diverse and realistic test datasets.
- Establish, track, report, and continually refine verification quality metrics.
- Continuously assess and improve system performance and scalability in partnership with peer leaders in engineering and product teams.
- Collaborate with cross-functional teams to enhance post-deployment monitoring capabilities.
- Serve as the primary engineering owner for quality-related audits, CAPA responses, and discussions regarding regulatory evidence.
- Lead and develop a global, multi-functional test organization, including internal and external SDETs, automation engineers, and system test engineers.
- Foster a robust engineering culture centered on quality, accountability, commitment, efficiency, trust, and high rigor.
- Oversee for test function staffing, resource planning, budgeting, tooling, test platforms, and third-party vendor relationships.
- Help promote a culture that values quality, teamwork, belonging, celebrating, continuous improvement, delivering meaningful innovation, and a high energy for getting things done with excellence.
Qualifications:
- 10+ years in software or test engineering, including 5+ years leading managers.
- Past success executing test strategies across multiple concurrent programs to ensure the on-time deployment of high-quality, performant medical software.
- Experience defining and owning the quality strategy for complex distributed systems within regulated environments.
- Guided testing for a wide array of technologies, including frontend, mobile, backend, services, data pipelines, microservices, and Machine Learning (ML) workflows.
- Proficient with automation frameworks (i.e. UI: Playwright, Cypress, Selenium/WebDriver, TestCafe | API: REST Assured, Karate, Postman, Pact (contract testing).
- Designed, scaled, and maintained End-to-End (E2E) automation frameworks covering complete workflows and system integrations.
- Experience with AWS and modern CI/CD (Continuous Integration/Continuous Deployment) systems.
- Strategic thinker with strong project management, interpersonal, and communication skills.
- Detail-oriented mindset with a proactive approach to problem-solving and decision-making.
- Excellent communication skills, capable of representing the engineering test function.
- Strong knowledge of quality and design control standards (i.e. ISO 13485, IEC 62304, ISO 14971, ISO 62366, 21 CFR Part 820).
Desired:
- Demonstrated ability to define, own, and evolve actionable quality metrics.
- Previous experience supporting Regulatory Affairs/Quality Assurance (RA/QA) teams during regulatory audits.
- Oversight into generation and management diverse test datasets (synthetic, anonymized, adversarial).
- Experience validating complex visualizations (both qualitative and quantitative).
- Experience with ML/AI system testing, clinical validation workflows, or medical imaging products.
- Background in non-functional testing tools (e.g., Locust, JMeter, Gatling, k6).
The Technical Project Manager is responsible for coordinating and managing cross-team and cross-department activities. This person will be well versed in the processes and procedures used to manage technical projects and release product and will be key in the facilitation of those efforts. This role is expected to work closely with the teams on schedules and deliverables involved while ensuring adherence to our design controls process. This role is expected to have the background necessary to operate at the team and release level but will operate primarily at the project level within the department. This role may also involve helping to coordinate release activities.
Ability to lead meetings, set action items, and keep owners accountable for their action items. Skilled at building detailed plans for software development projects, ensuring the relevant items, dependencies, and risks are identified, even with limited input. Good written and verbal communication skills. Good at understanding and communicating technical topics and issues at a high level. Outstanding organizational skills including ability to prioritize tasks efficiently with high level of attention to detail. Problem solver. Passionate about seeking ways to improve processes. Ability to deal with multiple projects.
A university degree with strong preference towards a software engineering background. Minimum of 4 years experience with strong preference towards experience in a software and medical industry. Or an advanced degree with minimum 2 years experience. Understanding of and experience with Agile development at scale. Experience with regulated SaaS products and/or software-as-a-medical-device (SAMD) preferred. Experience working with JIRA preferred.
A reasonable estimate of the yearly base compensation range is $240,000 to $280,000, bonus, and equity. #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/.
