Software Design Quality Engineer

About the role

The Software Design Quality Engineer ensures that medical device software meets the highest standards of safety, quality, and regulatory compliance throughout its lifecycle. You will lead design assessments, manage risk, and drive continuous improvement of software development processes.

Key responsibilities

• Lead assessment of software designs by reviewing test and performance data to uphold quality, safety, and regulatory standards.
• Develop and maintain software quality documentation, risk management plans, and traceability matrices.
• Conduct root‑cause analyses for software anomalies and implement corrective actions.
• Author and execute software test protocols, generate test reports, and monitor post‑market performance.
• Oversee regulatory planning, filing, and approval activities for new products and changes.

Required profile

• Minimum 5+ years experience in FDA‑regulated, IEC 62304 medical device software environments.
• Strong knowledge of Risk Management (ISO 14971), SDLC, and QMS related to software design controls.
• Proven experience with root‑cause analysis, software V&V, design traceability, and Design for Quality.
• Bachelor’s degree in Quality, Computer Science/Engineering or related field; ISTQB certification desired.

Required skills

• IEC 62304
• ISO 14971
• FDA regulations
• Software Verification & Validation (V&V)
• Root Cause Analysis
• Design for Quality (DfQ)
• Agile and SAFe methodologies
• C, C++, C# programming languages

What we offer

• Pay range $102,480 – $163,968 per year.
• Annual incentive bonus and long‑term incentives.
• Generous PTO, 401(k) match up to 7%, HSA contributions.
• Stock purchase plan, education reimbursement, and other comprehensive benefits.