Director of Quality Engineering

Sword Health; United States; Remote; USD 72,000 - 114,000; Full time

Job summary

Sword Health is seeking an experienced Director of QARA (Engineering) to define and lead our end-to-end quality strategy across SaMD software, AI/ML, and connected-device products, reporting to the VP of QARA.

You will own verification and validation, risk analysis per ISO 14971, define V&V strategies, and embed quality into the SDLC with CI/CD gates, audits, and regulatory submissions, coordinating with Engineering, Product, and AI teams to move fast and stay compliant.

Qualifications

• 7+ years in software quality engineering, with 5+ years leading quality organizations in a regulated environment.
• Hands-on experience with medical device software or comparable regulated domains, including IEC 62304, ISO 13485, ISO 14971, FDA 21 CFR Part 820 / QMSR and EU MDR.
• Proven track record building and scaling test automation and CI/CD quality practices across multiple product teams.
• Experience defining V&V strategies and producing evidence that stood up to audits or regulatory submissions.
• Strong technical credibility: able to review architectures, test frameworks, and code, and to coach engineers.
• Demonstrated people management capability, with a track record as a Team Lead or manager.
• Excellent communication and influence skills, with the ability to work with executives, engineers, clinicians, and regulators.

Responsibilities

• Help set the vision for quality in software/AI engineering across web, mobile, backend, firmware/hardware integration, and AI.
• Own software verification and validation (V&V) strategy for SaMD, ensuring traceability from requirements to test evidence.
• Help define how AI/ML systems are tested and monitored: model validation, dataset quality, bias and robustness testing, regression across versions, post-deployment monitoring.
• Embed quality into the SDLC: shift-left practices, CI/CD quality gates, automated regression, performance, security, accessibility testing, and fast, auditable release processes.
• Work within QARA to keep engineering processes aligned with the Quality Management System and serve as a technical authority during audits by notified bodies and authorities.
• Drive risk-based thinking with product and clinical teams on risk analysis, hazard mitigation, and verification of risk controls under ISO 14971.
• Evaluate and introduce tooling for test management, automation, and traceability.

Skills

Quality engineering

V&V strategies

Regulatory knowledge

CI/CD

Test automation

Code review

Communication

Tools

CI/CD pipelines

Job description

At Sword, we’re building AI to heal billions and unlock humanity’s full potential. In doing so, we’re pioneering AI Care, a fundamentally new approach to healthcare built for medical reasoning, safety, and real-time treatment, not generic technology applied after the fact. As both a clinical-centric frontier AI lab and an applied AI platform, Sword is reimagining how care is delivered at scale, removing traditional barriers like appointments, waiting rooms, and stigma so more people can access the care they need—and ultimately get back to lives lived in full.

Since 2020, Sword has expanded across physical therapy, women’s health, cardiometabolic, and mental health, and is now moving beyond the session to a fully AI-native, 24/7 care program that brings physical activity, therapeutic exercise, psychotherapy, nutrition, and behavior change into one connected experience. More than 700,000 members across three continents have completed over 10 million AI sessions, helping 1,000+ enterprise clients avoid more than $1 billion in unnecessary healthcare costs. Backed by 42 clinical studies, 44+ patents, and more than $500 million raised from leading investors including Khosla Ventures, General Catalyst, and Founders Fund, Sword is defining a new standard for healthcare.

AI Proficiency at Sword

AI fluency is a core expectation at Sword. Every candidate is assessed against our three-level framework — be ready to share real examples of how AI is already part of how you work.

• Explorer (Level 1) — Uses AI daily to boost personal productivity

• Builder (Level 2) — Creates workflows and tools that elevate the whole team

• Integrator (Level 3) — Embeds AI into products and processes at scale

Every hire must demonstrate at least Level 1. The expected level will vary depending on the seniority of the role.

Role

We are looking for an experienced Director of QARA (Engineering) to define and lead our end to end quality strategy across our Software as a Medical Device (SaMD) software, AI/ML, and connected-device products. Reporting to the VP of QARA, you will own how we build confidence in what we ship, from test automation and release readiness to verification and validation evidence that satisfies regulators. You will work closely with Engineering, Product, and AI teams to make sure we can move fast and stay compliant.

What you’ll be doing

• Help set the vision for quality in software/AI engineering across web, mobile, backend, firmware/hardware integration, and AI, where quality becomes a natural output of well-designed processes.
• Own software verification and validation (V&V) strategy for Software as a Medical Device (SaMD), ensuring rigorous, bi-directional traceability from requirements and risk controls through to test evidence.
• Help define how AI/ML systems are tested and monitored: model performance validation, dataset quality, bias and robustness testing, regression across model versions, and post-deployment drift and performance monitoring.
• Embed quality into the SDLC: shift-left practices, CI/CD quality gates, automated regression, performance, security, and accessibility testing, with release processes that are fast and auditable.
• Work within QARA to keep engineering processes aligned with the Quality Management System and serve as a technical authority during audits by notified bodies and authorities.
• Drive risk-based thinking, working with product and clinical teams on risk analysis, hazard mitigation, and verification of risk controls under ISO 14971.
• Evaluate and introduce tooling for test management, automation, and automated traceability, balancing build vs. buy.

What you need to have

• 7+ years in software quality engineering, with 5+ years leading quality organizations (managers and ICs) in a regulated environment.
• Hands-on experience with medical device software or comparable regulated domains, including working knowledge of IEC 62304, ISO 13485, ISO 14971, ISO/IEC 42001, IEC 81001-5-1 and FDA 21 CFR Part 820 / QMSR and/or EU MDR.
• Proven track record building and scaling test automation and CI/CD quality practices across multiple product teams.
• Experience defining V&V strategies and producing evidence that stood up to audits or regulatory submissions.
• Strong technical credibility: able to review architectures, test frameworks, and code, and to coach engineers.
• Demonstrated people management capability, with a proven track record as a Team Lead or manager directly hiring, mentoring, and steering technical quality teams.
• Excellent communication and influence skills, with the ability to work with executives, engineers, clinicians, and regulators.

*The range below reflects base, variable, and equity for this role.

This is a starting point, not a ceiling — once someone joins and proves they're outlier talent, we adjust quickly to make sure their compensation matches their impact.

Job titles may span more than one career level, so actual pay depends on skills, qualifications, experience, location, and market demand, among other factors. The range reflects base salary plus any variable, bonus, or sales incentives, and our estimate of the value of private company stock options where applicable. It's subject to change, and future stock value isn't guaranteed. Sword also offers additional benefits beyond total compensation.

Total Compensation Range

€64.400—€101.200 EUR

Country-specific benefits may vary and will be detailed separately.

Sword Health complies with applicable Federal and State civil rights laws and does not discriminate on the basis of Age, Ancestry, Color, Citizenship, Gender, Gender expression, Gender identity, Gender information, Marital status, Medical condition, National origin, Physical or mental disability, Pregnancy, Race, Religion, Caste, Sexual orientation, and Veteran status.