Senior Quality Software Engineer, Medical Device NPD

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

Benefits offered by this job

Competitive salary

Performance-based incentives

Benefits package

Job summary

Edwards Lifesciences in Irvine, CA is seeking a senior software engineer to coordinate design activities across the IHFM product suite, including digital apps and microservice platforms. You will ensure system designs meet regulatory requirements and drive test strategy and validation across multiple teams.

You will partner with hardware and quality teams to deliver compliant software solutions, champion Agile practices, and support regulatory submissions through robust validation and

Qualifications

• Experience with software design across medical device platforms and regulators.
• Familiarity with SDLC, V&V, design controls and traceability.
• Knowledge of medical device software standards (IEC 62304, ISO 13485, ISO 14971).
• Strong technical writing and cross-functional collaboration skills.
• Experience with Azure DevOps for test management and traceability.

Responsibilities

• Coordinate software design activities across UI, signal processing, DevOps and security.
• Work with hardware, mechanical, clinical and quality teams to meet requirements.
• Lead test system software development and validation activities.
• Develop verification strategies and testing methods for product requirements.
• Support end-to-end and system integration testing across platforms.
• Drive defect triage, quality assessment and root-cause analysis with cross-functional teams.
• Review test plans, protocols and reports ensuring alignment with FDA/IEC standards.
• Influence architecture with a strong software quality perspective.

Skills

Software design coordination

Agile/Lean

Technical writing

Cross-functional collaboration

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

Codebeamer

Jama

TestRail

Job description

Edwards Lifesciences in Irvine, CA is seeking a senior software engineer to coordinate design activities across the IHFM product suite, including digital apps and microservice platforms. You will ensure system designs meet regulatory requirements and drive test strategy and validation across multiple teams.

You will partner with hardware and quality teams to deliver compliant software solutions, champion Agile practices, and support regulatory submissions through robust validation and