Director of Quality Engineering, SaMD & AI/ML

Sword Health; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

Sword Health seeks a senior Software Quality Engineer to define and lead the quality strategy for SaMD, AI/ML, and connected devices. You will partner with Engineering, Product, and AI to balance speed with regulatory compliance.

You will own the V&V strategy and traceability for medical device software, embedding shift-left quality, CI/CD gates, and automation into the SDLC, and drive risk-based thinking to support audits and regulatory reviews.

Qualifications

• 7+ years as a software quality engineer, with 5+ years leading teams in regulated settings.
• Deep knowledge of medical device quality standards and regulatory requirements.
• Proven ability to scale test automation and CI/CD quality practices.

Responsibilities

• Define and lead quality strategy for SaMD, AI/ML, and connected devices.
• Partner with Engineering, Product, and AI to ensure speed and compliance.
• Own V&V strategy and traceability for medical device software.
• Embed shift-left quality, CI/CD gates, and automation into SDLC.
• Drive risk-based thinking and support audits.

Skills

Quality engineering leadership

Regulated environments

V&V strategy

CI/CD automation

Shift-left quality

Risk-based thinking

Tools

IEC 62304

ISO 13485

ISO 14971

FDA 21 CFR Part 820

Job description

Sword Health seeks a senior Software Quality Engineer to define and lead the quality strategy for SaMD, AI/ML, and connected devices. You will partner with Engineering, Product, and AI to balance speed with regulatory compliance.

You will own the V&V strategy and traceability for medical device software, embedding shift-left quality, CI/CD gates, and automation into the SDLC, and drive risk-based thinking to support audits and regulatory reviews.