Staff Quality Engineer – SaMD (Software as a Medical Device)

United States (Remote)
Full-Time

Salary Range: $152,000 – $228,000 per year

About the Role

We are seeking a highly experienced Staff Quality Engineer – SaMD to serve as a strategic partner to Product and Engineering teams. In this role, you will embed quality into the Software Development Lifecycle (SDLC) from concept through commercialization, ensuring software products are safe, effective, and compliant with U.S. and global medical device regulations.

You will act as the primary quality subject matter expert for our SaMD portfolio, helping engineering teams build compliant, audit-ready software efficiently while maintaining agility.

What You'll Do

Own the SDLC for SaMD

• Define, implement, and maintain SDLC processes aligned with FDA guidance and IEC 62304.

• Translate regulatory “waterfall” expectations into scalable Agile workflows.

• Ensure software lifecycle documentation supports regulatory submissions.

Partner with Engineering

• Integrate quality checkpoints into development workflows.

• Ensure proper execution of Design Controls (design inputs, architecture, verification & validation).

• Coach teams on compliance best practices.

Ensure Submission Readiness

• Own the Design History File (DHF) for software releases.

• Review artifacts for completeness and audit readiness.

• Support FDA and international regulatory submissions.

Lead Software Risk Management

• Drive risk management activities in accordance with ISO 14971.

• Facilitate hazard analysis and ensure effective risk control implementation.

Oversee Change & Release Management

• Ensure traceability and configuration control.

• Balance agile release cycles with regulatory documentation requirements.

• Evaluate post-release changes for safety and regulatory impact.

Drive QMS Excellence

• Lead CAPA investigations and root cause analysis.

• Support internal, FDA, and ISO audits.

• Develop training to simplify compliance for engineering teams.

Qualifications

Required

• Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or related field (Advanced degree preferred).

• 7+ years of experience in Quality Engineering, QA, or Software Development in regulated industries.

• 5+ years in Medical Device Software (SaMD/SiMD).

• 4+ years of Agile SDLC experience.

• Strong knowledge of:

  • IEC 62304

  • ISO 14971

  • 21 CFR Part 820 / ISO 13485

  • FDA Software Validation & Cybersecurity Guidance

Preferred

• Experience with AI/ML-enabled SaMD.

• Familiarity with modern tooling (Jira, Confluence, GitHub/GitLab, eQMS).

• Knowledge of medical device cybersecurity (AAMI TIR57).

• Experience with AWS/GCP environments and DevOps pipelines.

• Strong cross-functional leadership and communication skills.

Why Join

• High-impact role influencing product safety and regulatory strategy.

• Opportunity to shape software quality processes at scale.

• Competitive compensation: $152,000 – $228,000 annually (commensurate with experience and location).