Director, Regulated Software Delivery

Edwards Lifesciences Gruppe; Redhill (MD); On-site; USD 159,000 - 226,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA, seeks a Director, Software Systems, Process & Delivery to lead the IHFM sub-function responsible for regulated software and data product delivery. You will own delivery execution, release readiness, SSDLC, traceability, and design control discipline to ensure audit readiness and alignment with patient and regulatory needs.

You will manage managers and senior contributors, shaping end-to-end software delivery across multi‑team initiatives, with a focus on

Qualifications

• Experience leading Agile delivery across software, data, or technology teams.
• Experience with regulated product development and quality systems.
• Proven ability to drive end-to-end software delivery in a matrix organization.

Responsibilities

• Own delivery execution, release readiness, and traceability across IHFM software/data teams.
• Lead SSDLC, design control discipline, and audit-ready documentation.
• Partner with Quality, Regulatory, and cross-functional teams to ensure compliance.
• Manage managers and senior individual contributors to scale delivery.

Skills

Agile delivery leadership

Regulated software delivery

SDLC / design control

Cross-functional collaboration

Education

Bachelor's or Master's in related field

Tools

CI/CD tooling

DevSecOps

Regulatory tooling

Job description

Edwards Lifesciences in Irvine, CA, seeks a Director, Software Systems, Process & Delivery to lead the IHFM sub-function responsible for regulated software and data product delivery. You will own delivery execution, release readiness, SSDLC, traceability, and design control discipline to ensure audit readiness and alignment with patient and regulatory needs.

You will manage managers and senior contributors, shaping end-to-end software delivery across multi‑team initiatives, with a focus on