Senior SaMD Quality & Test Lead (Medical Devices)

Regulatory Jobs; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards is seeking a software quality-focused engineer to drive design across the Implantable Heart Failure Management product suite. You will work with hardware, clinical, and quality teams to ensure compliant software, robust V&V, and effective risk management.

You will develop test strategies, review plans in Azure DevOps, and lead cross-functional efforts to meet FDA, IEC 62304, ISO 13485, and ISO 14971 requirements. A strong SDLC background is essential.

Qualifications

• Bachelor's Degree in Engineering or related field with 4 years’ experience.
• Master's Degree or equivalent with 3 years’ experience.
• Ph.D. or equivalent with 0 years’ experience (Preferred).
• Experience with IEC 62304 Medical Device Software.
• Experience with hardware–software integration.
• Experience in medical device regulations standards and SDLC documentation.

Responsibilities

• Coordinate software design activities across IHFM product suite and platforms.
• Develop test strategies and V&V plans based on requirements and design.
• Support review of plans and reports in Azure DevOps to FDA/IEC/ISO standards.
• Lead QA activities with cross-functional teams in an Agile environment.
• Champion quality and risk discussions in architecture decisions.

Skills

Software design

Regulatory compliance

Azure DevOps

V&V

SDLC documentation

IEC 62304

ISO 13485

ISO 14971

Education

Bachelor's Degree in Engineering or related field

Master's Degree or equivalent

Ph.D. or equivalent

Tools

Azure DevOps

Jira

Jama

Codebeamer

Helix ALM

TestRail

Job description

Edwards is seeking a software quality-focused engineer to drive design across the Implantable Heart Failure Management product suite. You will work with hardware, clinical, and quality teams to ensure compliant software, robust V&V, and effective risk management.

You will develop test strategies, review plans in Azure DevOps, and lead cross-functional efforts to meet FDA, IEC 62304, ISO 13485, and ISO 14971 requirements. A strong SDLC background is essential.