Senior SaMD Quality Software Engineer – NPD

Edwards Lifesciences Gruppe; United States; On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences is seeking a software engineering leader for the Implantable Heart Failure Management (IHFM) team in the United States. You will coordinate design across mobile/web, microservices, and data platforms while guiding quality and regulatory compliance.

You will develop verification strategy and testing plans, work with hardware, clinical and quality teams, and drive end-to-end integration testing to ensure safety and effectiveness of implanted medical technologies.

Qualifications

• Bachelor’s degree in Engineering or related field with 4 years’ experience.
• Master’s Degree or equivalent in Engineering or related field, 3 years’ experience.
• Ph.D. or equivalent in Engineering or related field, 0 years’ experience.
• Experience with IEC 62304 Medical Device Software (preferred).
• Familiarity with FDA/IEC/ISO regulatory standards for medical devices.

Responsibilities

• Coordinate and oversee software design activities across the IHFM product suite including mobile/web, microservices, and data platforms.
• Maintain understanding of design considerations while contributing to Class B software system design.
• Coordinate design activities across UI, signal processing, DevOps, product security, and operating systems.
• Work with hardware, mechanical, clinical and quality teams to align requirements.
• Drive development and deployment of test systems and test methods concurrently with product development.
• Develop SW verification strategy, testing methods and V&V plans based on requirements.
• Support end-to-end and system integration testing across applications, platforms and data systems.
• Lead defect triage, quality assessment, and root-cause analysis with cross-functional teams.

Skills

Agile/Lean

Team collaboration

Problem-solving

Software verification

Regulatory awareness

Education

Bachelor’s Degree in Engineering or related field

Master’s Degree or equivalent in Engineering or related field

Ph.D. or equivalent in Engineering or related field

Tools

Azure DevOps (ADO)

Jira

Jama

CodeBeamer

Job description

Edwards Lifesciences is seeking a software engineering leader for the Implantable Heart Failure Management (IHFM) team in the United States. You will coordinate design across mobile/web, microservices, and data platforms while guiding quality and regulatory compliance.

You will develop verification strategy and testing plans, work with hardware, clinical and quality teams, and drive end-to-end integration testing to ensure safety and effectiveness of implanted medical technologies.