Director, Systems Engineering - SaMD

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world.

How you will make an impact:

Edwards Lifesciences is seeking a highly experienced technical leader to serve as Director, Systems Engineering - SaMD within the Transcatheter Mitral and Tricuspid Therapies (TMTT) organization.

This role will serve as the future technical owner of a next-generation software-enabled capital equipment platform and associated digital technologies supporting advanced structural heart therapies.

The successful candidate will provide systems leadership, architecture oversight, and technical ownership across the product lifecycle while partnering with geographically distributed engineering teams, OEM suppliers, and cross-functional stakeholders. This individual will influence technical strategy, system design, architecture decisions, product development execution, integration approaches, technical tradeoffs, risk management activities, and overall platform evolution.

This is not a traditional people-management role or a process-oriented systems engineering position. It is a Director-level technical leadership role intended for an experienced product builder who has personally developed and commercialized complex capital equipment, Software as a Medical Device (SaMD), or other software-enabled products and can apply that experience to evaluate architecture, technical strategy, resource needs, schedules, risks, and overall program execution.

The ideal candidate combines deep technical expertise with strong executive presence and can influence multidisciplinary organizations without direct authority. This role is an individual contributor initially, with the opportunity to build future systems engineering and integration capabilities as technical ownership transitions to Irvine and platform needs evolve.

Key Responsibilities:

• Lead end-to-end integration of a software-enabled capital equipment platform and associated digital technologies, ensuring alignment across hardware, electronics, firmware, software, Software as a Medical Device (SaMD), connectivity solutions, and user interfaces.
• Drive technical execution throughout the product lifecycle by evaluating system requirements, architecture, development plans, verification strategies, schedules, staffing assumptions, and overall program readiness.
• Identify and resolve system-level issues, integration risks, and execution gaps to support successful product development, commercialization, and long-term product performance.
• Serve as the technical leader and systems architecture authority for the platform, guiding system design, architecture development, technical decision-making, and long-term platform evolution while establishing technical ownership within the Irvine organization.
• Ensure architecture, requirements, and design decisions align with user needs, clinical workflows, human factors principles, regulatory expectations, cybersecurity requirements, and long-term business objectives.
• Apply systems thinking and Design for Excellence (DFX) principles when evaluating architecture, integration, and product decisions, balancing performance, reliability, quality, manufacturability, serviceability, supply chain considerations, cost, product lifecycle requirements, and commercialization readiness.
• Lead knowledge-transfer and ownership-transition activities from geographically distributed development teams while preserving technical knowledge, design intent, and architecture rationale.
• Partner with OEM suppliers, external development organizations, and internal stakeholders to ensure technical alignment, successful execution, and sustainable long-term platform support.
• Influence technical direction across Engineering, Quality, Regulatory Affairs, Clinical Affairs, Manufacturing, Operations, Program Leadership, and external partners.
• Communicate technical recommendations, risks, tradeoffs, and program health to engineering teams, functional leaders, and executive leadership while operating as a trusted technical authority who leads through expertise, credibility, collaboration, and sound engineering judgment.

This is a fully on-site role based at our corporate headquarters in Irvine, CA.

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