Director, Systems Engineering
$220K - $290K/yr(employer-provided)
Description
<div class="content-intro"><p>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 FFR<sub>CT&nbsp;</sub>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 (FFR<sub>CT&nbsp;</sub>Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis).&nbsp;Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.</p>
<p>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.&nbsp;&nbsp;</p></div><h2><strong>The Role</strong></h2>
<p>As the Director of Systems Engineering, you will lead the R&amp;D efforts for system-level design and architecture within our medical device software SDLC. You will be responsible for bridging the gap between unmet clinical needs and engineering execution, ensuring our SaMD products remain compliant, innovative, and patient-centric..</p>
<h2><strong>Key Responsibilities</strong></h2>
<ul>
<li><strong>Systems Architecture &amp; Design:</strong> Lead the end-to-end architecture for HeartFlow’s clinical software platform, focusing on new algorithms, reducing turnaround time and expanding clinical insights</li>
<li><strong>Human Factors Engineering (HFE):</strong> Manage the HFE function to ensure user-centric design is integrated into the SDLC, focusing on safety, usability, and clinical efficacy for medical professionals.</li>
<li><strong>Team Leadership:</strong> Scale and mentor a cross-functional engineering organization, reinforcing standardized design and review processes.</li>
<li><strong>Software SDLC &amp; Compliance:</strong> Oversee the systems engineering deliverables within a regulated environment, ensuring successful 510(k) clearances and adherence to design controls.</li>
<li><strong>Data-Driven Insights:</strong> Leverage SQL and Python to synthesize field data and clinical performance metrics to establish root cause and drive data-backed corrective actions.</li>
<li><strong>Performance Optimization:</strong> Partner with algorithm and software teams to define and track key performance metrics, ensuring high accuracy and reliability across all user needs.</li>
<li><strong>Continuous Improvement:</strong> Modernize design infrastructure and workflows to improve traceability, quality, and cross-functional alignment across the R&amp;D organization.</li>
</ul>
<h2><strong>What You Bring</strong></h2>
<ul>
<li><strong>Extensive Leadership:</strong> 10+ years of experience leading cross-functional teams spanning systems, test, and human factors engineering in regulated medical device environments.</li>
<li><strong>Proven Scaling Record:</strong> Demonstrated success in growing engineering organizations (e.g., scaling teams from 1 to 10+ engineers).</li>
<li><strong>Architecture Expertise:</strong> Proven track record of owning end-to-end architecture for complex diagnostic platforms, contributing to successful regulatory clearances.</li>
<li><strong>Analytical Power:</strong> High proficiency in using data analytics tools to drive root cause analysis and product improvement.</li>
<li><strong>Technical Foundation:</strong> Strong background in software integration and delivery.</li>
<li><strong>Educational Excellence:</strong> B.S. in Engineering or equivalent degree</li>
</ul>
<p><span data-sheets-root="1" data-sheets-value="{&quot;1&quot;:2,&quot;2&quot;:&quot;The Technical Project Manager is responsible for coordinating and managing cross-team and cross-department activities.\nThis 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. \nThis role is expected to work closely with the teams on schedules and deliverables involved while ensuring adherence to our design controls process. \nThis 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.\nThis role may also involve helping to coordinate release activities.&quot;}" data-sheets-userformat="{&quot;2&quot;:897,&quot;3&quot;:{&quot;1&quot;:0},&quot;10&quot;:0,&quot;11&quot;:4,&quot;12&quot;:0}"><span data-sheets-root="1" data-sheets-value="{&quot;1&quot;:2,&quot;2&quot;:&quot;Ability to lead meetings, set action items, and keep owners accountable for their action items\nSkilled at building detailed plans for software development projects, ensuring the relevant items, dependencies, and risks are identified, even with limited input.\nGood written and verbal communication skills.\nGood at understanding and communicating technical topics and issues at a high level.\nOutstanding organizational skills including ability to prioritize tasks efficiently with high level of attention to detail\nProblem solver.\nPassionate about seeking ways to improve processes.\nAbility to deal with multiple projects.&quot;}" data-sheets-userformat="{&quot;2&quot;:897,&quot;3&quot;:{&quot;1&quot;:0},&quot;10&quot;:0,&quot;11&quot;:4,&quot;12&quot;:0}"><span data-sheets-root="1" data-sheets-value="{&quot;1&quot;:2,&quot;2&quot;:&quot;A university degree with strong preference towards a software engineering background.\nMinimum of 4 years experience with strong preference towards experience in a software and medical industry.\nOr an advanced degree with minimum 2 years experience.\nUnderstanding of and experience with Agile development at scale.\nExperience with regulated SaaS products and/or software-as-a-medical-device (SAMD) preferred.\nExperience working with JIRA preferred.&quot;}" data-sheets-userformat="{&quot;2&quot;:897,&quot;3&quot;:{&quot;1&quot;:0},&quot;10&quot;:0,&quot;11&quot;:4,&quot;12&quot;:0}"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;"><span style="font-weight: 400;">A reasonable estimate of the yearly base compensation range is $220,000 to $290,000</span></span></span></span></span><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">, cash bonus, and equity. #LI-Hybrid</span></p><div class="content-conclusion"><div>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.</div>
<div>&nbsp;</div>
<div>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.</div>
<div>&nbsp;</div>
<div>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&nbsp;<a href="https://www.heartflow.com/about/careers/">www.heartflow.com/about/careers/</a>.&nbsp;</div></div>
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CardiovascularITSan Francisco, California
HeartFlow
BIOTECHNOLOGY
Coronary heart diseases assessment
LocationMOUNTAIN VIEW, CA
Open Jobs54
Pipeline
Exploring the MEchanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography aN/A
CMR and CTCA with CT-FFRN/A
Coronary computed tomography angiographyN/A
AI-enabled quantitative coronary plaque analysisN/A
FFRCTN/A