New · posted Oct 15
HeartFlow · Medical Devices
Principal Device Quality Engineer
- San Francisco, CA
- Hybrid
- Full-time
- Senior & Principal
Open until filled
The role
As the Principal Device Quality Engineer, you will serve as the global subject matter expert (SME) for software quality and design excellence. You will bridge 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 overseeing compliance around the end to end design control process within the Heartflow’s Software Development Lifecycle (SDLC), advising on everything from initial architecture and security-by-design to global regulatory submissions and post-market surveillance.
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 750,000 patients worldwide.
What you need
Educational Requirements & Work Experience
- Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field is required; a Master’s degree is strongly preferred.
- 10+ years of experience in quality engineering or product development within the medical device industry.
- Certifications (Preferred): ASQ Certified Quality Engineer (CQE), Certified Software Quality Engineer (CSQE), or Six Sigma Black Belt.
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/.
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
What you'll do
Strategic Leadership
- SME Guidance: Act as the primary authority on global regulatory standards, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45.
- Modern SDLC Evolution: Lead the integration of modern technologies into the Quality Management System (QMS), specifically defining validation frameworks for AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1).
- Agile Transformation: Partner with engineering teams to implement "Compliance at Speed," applying Agile best practices while maintaining total regulatory rigor. Commit to execution to ensure predictable, complete, high quality releases.
Design Quality & Risk Management
- Technical Architecture Review: Advise on software architecture through the lens of safety, security-by-design, and privacy-by-design.
- Advanced Risk Analysis: Support comprehensive risk management activities, including Hazard Analysis, Fault Tree Analysis (FTA), and FMEAs (Design and Software), specifically addressing software-driven failure modes.
- V&V Oversight: Technical lead for Software Verification and Validation (V&V); review and approve test strategies, protocols, and reports to ensure robust product performance.
Execution & Compliance
- DHF Management: Drive compliance from concept to commercialization, overseeing the Design History File (DHF) and ensuring a seamless design transfer.
- Audit Representation: Represent the organization’s software QMS during internal and external audits and inspections (e.g., FDA, Notified Body, MDSAP).
Cross-Functional Collaboration
- Regulatory Submissions: Collaborate with Regulatory Affairs to author technical documentation for global bodies, including FDA, PMDA, and EU-MDR.
- Mentorship: Provide high-level technical guidance and training to R&D, Product and Program.
Pay and benefits
$188,000 – $240,000 a year
Employer providedThis position has an estimated base salary of $188,000 - $240,000, bonus, and equity. ; #Hybrid
Bonus
Equity
Where you'll work
San Francisco, CAHybridOpen in Maps (opens in a new tab)
More jobs in San Francisco, CAEqual opportunity, accessibility and legal noticesHeartFlow's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 74% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in California84 roles publishing pay
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $188,000 | — | $240,000 |
| California (middle half) | $118,625 | $135,000 | $158,625 |
| All US (middle half) | $103,375 | $122,750 | $137,500 |
This role: HeartFlow's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not HeartFlow's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Data and digital systems8
- GMP and compliance6
- Quality systems and risk5
- Documentation and SOPs3
- Lab testing and methods2
- Validation and qualification2
- Regulatory submissions2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device software
- FDA and partnersMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program
Company hiring pulse
HeartFlow on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 1
- Locations
By discipline
- Quality3 60%
- Regulatory1 20%
- Compliance & Safety1 20%
By level
- Senior & Principal3 60%
- Director1 20%
- Manager1 20%
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Principal Device Quality Engineer at HeartFlow
Open until filled. $188K–$240K a year, employer provided.