Senior Software Quality Engineer – SaMD & MedTech

Edwards Lifesciences; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences is seeking a Senior Software Engineer to lead design across the Implantable Heart Failure Management (IHFM) software suite, including digital applications and data platforms. You will collaborate with hardware, clinical, and quality teams to ensure compliant, high-quality system design and validation.

Qualifications include engineering degrees at various levels and experience with regulatory standards (FDA/IEC 62304/ISO 13485/ISO 14971).

Qualifications

• Bachelor’s Degree in Engineering or related field with 4+ years’ experience, or
• Master’s Degree with 3+ years’ experience, or
• Ph.D. with equivalent in Engineering or related field (preferred)

Responsibilities

• Coordinate and oversee software design across IHFM product suite (mobile/web, microservices)
• Ensure design considerations for Class B software systems
• Collaborate with hardware, mechanical, clinical and quality teams
• Drive development and deployment of test systems software and automation
• Develop verification strategy, testing methods, and V&V plans
• Support end-to-end and system integration testing across apps, platforms and data systems
• Lead defect triage, quality assessment, and root-cause analysis with cross-functional teams
• Review test plans, protocols, and reports in Azure DevOps ensuring FDA/IEC/ISO alignment
• Influence architecture and risk discussions with a software quality perspective
• Shape system requirements with R&D and support regulatory submissions and validation

Skills

Software design leadership

Cross-functional collaboration

Analytical/problem solving

Regulatory awareness

Communication

Education

Bachelor’s Degree in Engineering

Master’s Degree in Engineering

Ph.D. in Engineering

Tools

Azure DevOps

Jira

CodeBeamer

Job description

Edwards Lifesciences is seeking a Senior Software Engineer to lead design across the Implantable Heart Failure Management (IHFM) software suite, including digital applications and data platforms. You will collaborate with hardware, clinical, and quality teams to ensure compliant, high-quality system design and validation.

Qualifications include engineering degrees at various levels and experience with regulatory standards (FDA/IEC 62304/ISO 13485/ISO 14971).