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.

At Edwards Lifesciences, the Implantable Heart Failure Management (IHFM) AI, Product and Platforms organization designs and builds the software and data products that clinicians and patients depend on. As a Lead Designer, you set the design direction for a product area and lead its design systems and usability engineering work. This is the entry level of the Subject Matter Expert (SME) track, where you combine deep design craft with technical and regulatory fluency. You are accountable for how IHFM products in your area look, feel, and perform for clinicians and patients, and for the software human factors evidence that supports their safe use.

How you'll make an impact

• Set the design direction for a significant product area and ensure design quality and consistency across its features.

• Lead design systems work for your area, owning components, patterns, accessibility standards, and contribution guidelines.

• Lead usability engineering activities, including planning and overseeing formative and summative usability testing and use-error analysis that support regulatory submissions under IEC 62366-1.

• Act as a Human Factors Engineering (HFE) contributor for Software as a Medical Device, partnering with research & development, quality, regulatory, and clinical stakeholders.

• Influence product strategy alongside cross-functional marketing product management, technical product management, software engineering, and data engineering leadership, and mentor designers across levels.

What you'll need (Required):

• Bachelor's degree in design, human-computer interaction, software human factors, or a related field plus eight years of design experience, including leading the design of a major product area or equivalent work experience based on Edwards criteria

• Deep proficiency with Figma and the team's research and usability toolset (e.g., Dovetail and / or UserTesting), design systems, and prototyping.

• Experience planning and running formative and summative usability testing and applying software human factors methods.

• This is an onsite role based in Irvine, CA. Relocation assistance is not provided, and candidates must reside within a 50-mile radius of Irvine to be considered.

What else we look for (Preferred):

• The ability to communicate design rationale to senior stakeholders and to drive alignment across functions.

• A track record of shipping high-quality design and improving outcomes through research and iteration.

• Direct experience with usability engineering for medical devices (IEC 62366-1), including contributing to a usability engineering file or design history file.

• Familiarity with SaMD regulatory expectations and quality management systems.

• Experience owning a cross-product design system and accessibility framework.