Senior Device Quality Engineer

Job Description

As the **Senior Device Quality Engineer**, you will serve as a key technical lead 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 the hands-on management 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.

**Key Responsibilities**

Technical Leadership

* **Standards Execution:** Apply global regulatory standards, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45, to daily development activities.
* **SDLC Support:** Implement validation frameworks for AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1) within the Quality Management System (QMS).
* **Agile Integration:** Partner with engineering teams to execute "Compliance at Speed," ensuring Agile sprints meet all regulatory rigor and result in high-quality, predictable releases.

Design Quality \& Risk Management

* **Design Reviews:** Participate in software architecture reviews to ensure the implementation of safety-by-design and privacy-by-design principles.
* **Risk Analysis:** Facilitate and document comprehensive risk management activities, including Hazard Analysis, Fault Tree Analysis (FTA), and Software FMEAs.
* **V\&V Execution:** Act as the lead for Software Verification and Validation (V\&V); develop and execute test strategies, protocols, and reports to ensure product performance.

Execution \& Compliance

* **DHF Ownership:** Manage the Design History File (DHF) from concept to commercialization, ensuring all documentation is audit-ready and design transfer is seamless.
* **Audit Support:** Support the organization during internal and external audits (e.g., FDA, Notified Body, MDSAP) as a subject matter expert for software processes.

Cross-Functional Collaboration

* **Technical Documentation:** Support Regulatory Affairs in authoring technical files for global submissions, including FDA (510k/De Novo), PMDA, and EU-MDR.
* **Team Guidance:** Provide technical coaching and quality training to R\&D and Product teams to foster a culture of compliance.

**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.

**Educational Requirements \& Work Experience**

* Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field is required.
* **5--8 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 Green Belt.

This position has an estimated base salary of $160,000 - $180,000, bonus. #LI-IB1; LI-Hybrid