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

Senior Device Quality Engineer

Responsibilities

Company

Heartflowinc

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