Senior Quality Software Engineer, NPD - IHFM

$108k - $153k

Edwards Lifesciences Corp.

Edwards Lifesciences seeks a Senior Quality Software Engineer for their Implantable Heart Failure Management division in Irvine, California. The role involves overseeing software design activities, developing verification strategies, and ensuring compliance with medical device regulations across digital applications, microservices, and data platforms.

Responsibilities

Coordinate and oversee software design activities across digital applications, microservices, and data platforms
Develop software verification strategy, testing methods, and V&V plans aligned with regulatory standards
Drive defect triage, quality assessment, and root-cause analysis with cross-functional teams
Support complex end-to-end and system integration testing across applications and platforms
Champion Agile and Lean methodologies to embed quality early in the development lifecycle

Requirements

Bachelor's degree in engineering or related field with 4+ years of industry experience
Experience with IEC 62304 medical device software standards and FDA regulations
Proficiency in Azure DevOps for test management and Agile execution
Strong technical writing skills and knowledge of SDLC documentation
Experience with hardware-software integration and system testing
Familiarity with design control processes for medical devices or SaMD

Compensation: $108,000-$153,000 base

Apply

Vacancy posted 2 days ago

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