Sr Director, Software Development

Edwards Lifesciences•Irvine, CA

2d•$191,000 - $271,000•Onsite

About The Position

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) business’s AI, Product and Platforms organization is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It is our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. As a leader within the Software Engineering discipline, you guide the product development teams that build our digital application ecosystem: The customer-facing web and mobile (iOS and Android) applications, the closely coupled backend-for-frontend (BFF) layer that serves them, and the software tools and applications that support product development and all other business operations. This is a hands-on leadership role. You are accountable for the people who do this work, for staying technically engaged in it yourself, and for the quality, safety, and timely delivery of regulated Software as a Medical Device (SaMD) applications.

Requirements

Must work on-site at Irvine HQ (no remote).
Bachelor’s degree in computer science, software engineering, or a related field.
The broadest technical range on the track, with medium-level, current depth across the organization’s full landscape (digital application ecosystem, application platform, data platform, and interoperability standards), sufficient to set architecture direction and engage credibly with the most senior individual contributors.
A willingness to remain hands-on through architecture and design review and critical co-debugging.
Demonstrated mastery of team design, talent and succession strategy, and multi-year technical and business planning.
Exceptional communication and executive presentation skills, including external customer- or partner-level communication and cross-functional influence.
Accountability for regulated software portfolios, including audit and regulatory submission outcomes.
Experience as a hands-on people leader with multiple tiers of direct reports, and HR responsibilities including hiring, career development, mentoring, performance reviews, and succession planning.

Nice To Haves

15+ years of software development, including leadership (or 14 years with a master’s, or 11 years with a PhD).
Deep experience in medical device software (SaMD), or other regulated classes of device software, including FDA submissions, audits, and regulatory strategy (IEC 62304, ISO 13485, IEC 62366-1, FDA design controls).
History of building and scaling engineering teams through significant growth or transformation.
Strong problem-solving ability and comfort navigating ambiguity, with a track record of leading teams through change.
Executive-level communication experience.

Responsibilities

Drive the long-term, multi-year strategy for how IHFM builds and evolves its customer-facing applications and software tools, including application architecture, modernization, and platform direction.
Blend comprehensive, multi-disciplinary technical knowledge with solid practical execution: be fluent enough across the organization’s entire technology landscape, spanning the digital application ecosystem (web, mobile for iOS and Android, the BFF or backend-for-frontend layer, and the full UI framework, design-system, and data visualization ecosystem), the application platform (.NET Core, Java, Python, GoLang, Rust), and the data platform (Python, Scala), as well as interoperability standards (HL7, FHIR, IHE), to set architecture direction across families and challenge senior individual contributors constructively.
Remain hands-on, credible at the most senior level: retain the willingness and ability to drop into architecture reviews, design reviews, and critical co-debugging, and stay technically current so your judgment is grounded in the real system. Hands-on credibility is non-negotiable, even here.
Lead product development teams across the Software Engineering (Applications & Tools) discipline and the broader digital application ecosystem, managing other technical leaders and developers, and setting the leadership structure for the area.
Lead team design, talent strategy, budget, and succession at scale: leveling and calibration integrity, the leadership pipeline, and the software engineering culture and standards for the area; mentor staff members from all levels within your teams.
Be accountable to executive leadership for the safety, quality, regulatory standing, and delivery of a major part of the SaMD product portfolio, ensuring the QMS and design controls remain effective at scale, and the organization remains consistently audit-ready and submission-ready for FDA and other regulators.
Define and track the engineering metrics that show delivery health and the value of product development to the business, and use them to guide investment and improvement.
Lead through communication and presentation, where it matters most: represent product development to executive and senior leadership and, where appropriate, customers and partners; present application strategy, risk, and investment cases; partner with executive peers across Product, Design, R&D, Regulatory, Quality, Clinical, and Platform; and advocate for the organization’s priorities, headcount, and technical investment.