Senior Quality Software Engineer, NPD - IHFM
Edwards Lifesciences · Irvine, CA
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Role summary
Edwards Lifesciences seeks a Senior Quality Software Engineer to oversee software design and verification for heart failure management devices. The role involves coordinating design across digital applications, microservices platforms, and data systems while developing testing strategies aligned with FDA and IEC 62304 standards. Candidates need a bachelor's degree in engineering with four years of related experience, or advanced degree with less experience required.
What they're looking for
- Bachelor's degree in Engineering or related field with 4+ years industry experience
- Master's degree in Engineering or related field with 3+ years industry experience
- IEC 62304 medical device software experience
- Hardware-software integration and system testing expertise
- Azure DevOps proficiency for test management and traceability
- FDA, ISO 13485, and ISO 14971 regulatory standards knowledge
- Strong technical writing and cross-functional collaboration skills
What you'll be doing
- Oversee software design activities across digital applications, microservices, and data platforms
- Develop verification strategies, testing methods, and V&V plans aligned with regulatory standards
- Drive end-to-end system integration testing and defect triage with root-cause analysis
- Partner with R&D and cross-functional teams to shape requirements and system design
- Champion Agile methodologies to embed quality early in product development lifecycle
Privacy & handoff
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