Senior Quality Software Engineer – SaMD & Medical Device Systems
Edwards Lifesciences Gruppe
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Job summary
Edwards Lifesciences Gruppe is seeking a software-focused engineer to drive design across the IHFM product suite, including digital apps, microservices, and data platforms. You will collaborate with hardware, clinical, and quality teams to ensure compliant, robust software solutions and lead test system development and V&V planning.
The ideal candidate has a strong background in medical device software, regulatory standards (FDA/IEC 62304), and experience with Azure DevOps, with excellent
Qualifications
- Bachelor's degree in Engineering or related field required.
- Master's degree or PhD preferred or equivalent experience.
- Experience with IEC 62304 medical device software is a plus.
- Experience in software/hardware system testing, data acquisition and analysis.
- Strong technical writing skills and experience with regulatory standards.
Responsibilities
- Coordinate and oversee software design activities across IHFM product suite (digital apps, microservices, data platforms).
- Work with hardware, mechanical, clinical and quality teams to ensure design meets requirements.
- Lead test system software and automation development; contribute to V&V plans.
Skills
Education
Tools
Job description
Edwards Lifesciences Gruppe is seeking a software-focused engineer to drive design across the IHFM product suite, including digital apps, microservices, and data platforms. You will collaborate with hardware, clinical, and quality teams to ensure compliant, robust software solutions and lead test system development and V&V planning.
The ideal candidate has a strong background in medical device software, regulatory standards (FDA/IEC 62304), and experience with Azure DevOps, with excellent
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