Lead Designer, UX

📍 Job Overview

Job Title: Lead Designer, UX

Company: Edwards Lifesciences

Location: Irvine, California, United States

Job Type: Full time

Category: UX Design & Human Factors Engineering

Date Posted: September 11, 2026

Experience Level: 8+ Years (SME Track)

Remote Status: On-site

🚀 Role Summary

• Lead the UX design direction and strategy for a significant product area within the Implantable Heart Failure Management (IHFM) AI, Product and Platforms organization.

• Own and evolve the design systems, including components, patterns, accessibility standards, and contribution guidelines to ensure design consistency and quality.

• Spearhead usability engineering activities, encompassing planning and execution of formative and summative usability testing to support regulatory submissions.

• Serve as a key Human Factors Engineering (HFE) contributor for Software as a Medical Device (SaMD), collaborating with R&D, Quality, and Regulatory teams.

• Drive product strategy discussions and mentor junior designers, fostering a culture of design excellence and user-centricity.

📝 Enhancement Note: This role is positioned as an entry-level Subject Matter Expert (SME) on the design track, indicating a need for deep craft, technical understanding, and regulatory fluency within the medical device software domain. The emphasis on IEC 62366-1 and SaMD suggests a highly regulated environment requiring meticulous documentation and adherence to standards.

📈 Primary Responsibilities

• Define and champion the UX design vision and strategy for a designated product domain, ensuring alignment with overall business objectives and patient needs.

• Lead the development and maintenance of comprehensive design systems, ensuring scalability, consistency, and adherence to accessibility standards (e.g., WCAG).

• Plan, execute, and analyze formative and summative usability testing, generating robust human factors evidence to support regulatory compliance under IEC 62366-1.

• Collaborate closely with cross-functional teams, including Product Management, Software Engineering, Data Engineering, Quality Assurance, and Regulatory Affairs, to integrate UX insights into product development lifecycles.

• Actively participate in product strategy sessions, influencing roadmaps and prioritizing UX initiatives based on user research, market analysis, and regulatory requirements.

• Mentor and guide other designers, providing constructive feedback and fostering their professional growth within the design team.

• Contribute to the creation and maintenance of the Usability Engineering File and Design History File (DHF) for medical device software products.

• Advocate for the user throughout the product development process, ensuring that designs are intuitive, efficient, and safe for clinicians and patients.

📝 Enhancement Note: The responsibilities highlight a dual focus on design leadership and deep technical/regulatory expertise. The requirement to lead usability engineering and contribute to regulatory submissions points towards a significant operational component beyond traditional UX design.

🎓 Skills & Qualifications

Education: Bachelor's degree in Design, Human-Computer Interaction (HCI), Software Human Factors, or a closely related field.

Experience: A minimum of eight years of progressive design experience, with a proven track record of leading the design of a major product area or equivalent experience as defined by Edwards Lifesciences' criteria.

Required Skills:

• Deep proficiency in UX design principles and methodologies.

• Extensive experience with Figma for design, prototyping, and collaboration.

• Hands-on experience with research and usability tooling such as Dovetail and/or UserTesting.

• Proven ability to lead and manage design systems, including component libraries, pattern definition, and contribution guidelines.

• Demonstrated experience in planning, conducting, and analyzing formative and summative usability testing.

• Strong understanding of software human factors methods and their application in product development.

• Excellent communication and presentation skills, with the ability to articulate design rationale to senior stakeholders and drive cross-functional alignment. Preferred Skills:

• Direct experience with usability engineering for medical devices, specifically adhering to IEC 62366-1 standards.

• Familiarity with Software as a Medical Device (SaMD) regulatory expectations and quality management systems (e.g., ISO 13485).

• Experience contributing to a Usability Engineering File or Design History File (DHF).

• Proven ability to ship high-quality designs that demonstrably improve user outcomes through research and iteration.

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

• Familiarity with data engineering and AI product development processes.

📝 Enhancement Note: The required skills strongly emphasize practical application in a regulated medical device context. The preference for direct medical device usability engineering experience and SaMD knowledge is critical for candidates to highlight.

📊 Process & Systems Portfolio Requirements

Portfolio Essentials:

• Showcase a minimum of two comprehensive case studies demonstrating leadership in designing a significant product area from concept to launch.

• Include detailed examples of design system contributions, illustrating ownership of components, patterns, and accessibility standards.

• Present detailed usability engineering projects, including the planning, execution, and analysis of formative and summative testing, with clear links to regulatory requirements (e.g., IEC 62366-1).

• Demonstrate how your design decisions and research led to measurable improvements in user experience, efficiency, or safety, with quantitative data where possible.

• Highlight your experience with Figma, including complex prototyping and design system management. Process Documentation:

• Provide examples of how you have documented design processes, including workflow design and optimization phases, for your product areas.

• Illustrate your approach to implementing and automating design system updates and usability testing protocols.

• Include examples of how you measure and analyze the performance and impact of your design solutions and processes.

📝 Enhancement Note: For this role, the portfolio must go beyond visual design. It needs to explicitly showcase a candidate's ability to lead, manage complex design systems, and crucially, demonstrate a deep understanding and practical application of usability engineering processes within a regulated medical device environment.

💵 Compensation & Benefits

Salary Range: The base pay range for this position in Irvine, California, is $126,000 - $178,000 annually for highly experienced candidates.

Benefits:

• Competitive salaries that reflect your expertise and contributions.

• Performance-based incentives to reward outstanding achievements and drive business success.

• A diverse and comprehensive benefits program designed to support the individual needs of employees and their families, potentially including health insurance, retirement plans, paid time off, and professional development opportunities.

Working Hours: Standard full-time position, typically 40 hours per week, with potential for flexibility based on project needs and team collaboration.

📝 Enhancement Note: The salary range is provided for a highly experienced candidate, suggesting that the compensation will be commensurate with the SME level and extensive experience required. The benefits are described generally but emphasize a comprehensive approach to employee well-being and performance recognition, which is typical for a large medical device company.

🎯 Team & Company Context

🏢 Company Culture

Industry: Medical Devices, specifically focusing on Structural Heart Disease and Heart Failure Management. Edwards Lifesciences is a global leader in this sector, known for its innovation and patient-centric approach.

Company Size: Edwards Lifesciences is a large, established public company (likely a Fortune 500 company given its industry leadership). This implies a structured environment with established processes, significant resources, and a global presence.

Founded: Founded in 1958, Edwards Lifesciences has a long history of innovation in medical technology. This longevity suggests a stable organization with deep expertise and a commitment to long-term patient care solutions.

Team Structure:

• The role is within the Implantable Heart Failure Management (IHFM) business unit, specifically within the AI, Product and Platforms organization. This indicates a focus on cutting-edge technology, including AI, software development, and data products for medical applications.

• The Lead Designer will be part of a cross-functional team that includes Product Management, Software Engineering, Data Engineering, Quality Assurance, and Regulatory Affairs.

• This role operates on the Subject Matter Expert (SME) track, signifying a path for deep specialization and technical leadership rather than people management. Methodology:

• The organization utilizes a combination of agile development methodologies for software and rigorous processes for medical device design and validation, adhering to standards like IEC 62366-1.

• Data analysis and AI are integral to the product development process, aiming to provide early, targeted therapeutic interventions for patients.

• A strong emphasis is placed on user-centric design and robust human factors engineering to ensure the safety and efficacy of medical devices.

Company Website: https://www.edwards.com/

📝 Enhancement Note: The company context underscores the critical nature of the work performed at Edwards Lifesciences and the regulatory rigor required. The IHFM business unit's focus on AI and advanced platforms suggests a forward-thinking approach within a well-established medical technology company.

📈 Career & Growth Analysis

Operations Career Level: This position is at the Subject Matter Expert (SME) level, specifically a "Lead Designer." It signifies a senior individual contributor role focused on deep expertise in UX design, design systems, and usability engineering within the medical device software domain. The role involves setting design direction and leading technical efforts rather than managing a team.

Reporting Structure: The Lead Designer will likely report to a Design Director, Head of UX, or a similar senior leadership role within the IHFM AI, Product and Platforms organization. They will collaborate closely with Product Managers, Engineering Leads, and Quality/Regulatory stakeholders.

Operations Impact: The Lead Designer's work directly impacts the safety, efficacy, and usability of critical medical devices for heart failure patients. Their contributions are essential for regulatory approval, successful product adoption by clinicians, and ultimately, improving patient outcomes and quality of life. This role has a direct influence on the company's ability to deliver life-saving technologies.

Growth Opportunities:

• Specialization: Deepen expertise in specific areas like AI-driven UX, advanced medical device interfaces, or specialized usability engineering for SaMD.

• Technical Leadership: Progress to a Senior SME or Principal Designer role, taking on even larger product areas or influencing company-wide design system strategies.

• Cross-functional Influence: Develop stronger strategic partnerships with Product Management, Engineering, and Regulatory teams, potentially influencing broader product roadmaps and company-wide design standards.

• Mentorship: Continue to mentor and develop junior designers, contributing to the growth of the UX talent within Edwards Lifesciences.

📝 Enhancement Note: The SME track at Edwards Lifesciences offers a clear path for technical experts to grow without necessarily moving into people management. The emphasis on impact and growth within specialized areas is a key selling point for senior individual contributors.

🌐 Work Environment

Office Type: This is an on-site role based in Irvine, CA. The work environment is likely a professional office setting within Edwards Lifesciences' facilities, designed for collaboration and focused work.

Office Location(s): The primary work location is Irvine, California, USA. Candidates are required to reside within a 50-mile radius of Irvine.

Workspace Context:

• The workspace will support collaboration with cross-functional teams (Product Management, Engineering, Quality, Regulatory) through in-person meetings, design reviews, and shared digital platforms.

• Access to necessary design and usability tools, including Figma, Dovetail, and UserTesting, will be provided.

• The environment will likely foster a culture of innovation within the regulated medical device industry, balancing creative design with stringent compliance requirements.

Work Schedule: The role is full-time, typically 40 hours per week. While on-site, there may be opportunities for some schedule flexibility, common in professional office settings, to accommodate project needs and personal well-being.

📝 Enhancement Note: The strict on-site requirement and 50-mile radius stipulation are important for candidates to note. The environment is described as professional and collaborative, typical for a large, established medical technology company.

📄 Application & Portfolio Review Process

Interview Process:

• Initial Screening: HR or Recruiter will review applications and conduct an initial screening call to assess basic qualifications and cultural fit.

• Hiring Manager Interview: A conversation with the hiring manager to delve deeper into experience, leadership capabilities, and understanding of the role's responsibilities.

• Portfolio Review & Design Challenge: This is a critical stage where candidates present their portfolio, highlighting relevant case studies, design systems, and usability engineering work. A design challenge or detailed discussion on a specific problem may be included to assess problem-solving skills and design craft.

• Cross-functional Stakeholder Interviews: Interviews with key team members from Product Management, Engineering, Quality, and Regulatory to assess collaboration skills and functional expertise.

• Final Interview: Potentially a discussion with senior leadership to confirm fit and strategic alignment.

Portfolio Review Tips:

• Curate Strategically: Focus on 2-3 in-depth case studies that best represent your leadership in design systems and usability engineering for complex products, ideally in regulated environments.

• Show, Don't Just Tell: Clearly articulate the problem, your role, the process you followed (design thinking, HFE methods), your specific contributions, the solutions, and the measurable impact (user outcomes, regulatory success).

• Highlight Process & Rationale: For each case study, explain why you made certain design decisions and how your usability testing informed those decisions and supported regulatory compliance.

• Demonstrate Tool Proficiency: Be ready to walk through your Figma files, design system components, and usability testing documentation.

• Emphasize Regulatory Acumen: Clearly explain your experience with IEC 62366-1 and SaMD, showcasing how you integrated these requirements into your design and testing processes.

Challenge Preparation:

• Understand the Context: Be prepared for challenges that involve designing for medical devices, considering user safety, regulatory constraints, and technical feasibility.

• Think Aloud: Articulate your thought process clearly during any problem-solving exercises. Focus on user needs, potential risks, and how you would mitigate them.

• Prioritize & Justify: If given a complex problem, demonstrate your ability to prioritize tasks and justify your approach based on impact and feasibility.

📝 Enhancement Note: The portfolio review is paramount for this role. Candidates must be prepared to showcase not only design excellence but also a deep, practical understanding of human factors engineering and regulatory compliance in the medical device industry.

🛠 Tools & Technology Stack

Primary Tools:

• Figma: Essential for UI design, prototyping, and collaborative design system development. Deep proficiency is required.

• Design System Management Tools: Experience with tools or methodologies for creating, maintaining, and scaling design systems.

• Prototyping Tools: Beyond Figma, familiarity with other prototyping tools may be beneficial.

Analytics & Reporting:

• Usability Testing Platforms: Dovetail and/or UserTesting are specifically mentioned as part of the team's toolset for qualitative and quantitative user research and usability testing.

• Analytics Tools (General): While not explicitly listed, familiarity with general product analytics tools that help track user behavior and feature adoption may be advantageous for understanding product performance post-launch.

CRM & Automation:

• Regulatory Compliance Software: Familiarity with systems used for managing Design History Files (DHF), Usability Engineering Files, and quality management systems is highly preferred.

• Collaboration & Project Management Tools: Standard tools like Jira, Confluence, or similar platforms for team collaboration and project tracking are likely used.

📝 Enhancement Note: The emphasis on Figma and specific usability testing tools (Dovetail, UserTesting) is critical. Candidates should be prepared to discuss their experience and expertise with these platforms and how they leverage them to support design and regulatory processes.

👥 Team Culture & Values

Operations Values:

• Patient Focus: A core value that drives all product development, ensuring that designs prioritize patient safety, well-being, and improved health outcomes.

• Innovation: A commitment to pioneering new technologies, such as AI, to address unmet patient needs in heart failure management.

• Quality & Compliance: A rigorous adherence to high standards in design, development, and regulatory processes, critical for medical devices.

• Collaboration: A strong emphasis on cross-functional teamwork, valuing input and expertise from all disciplines to achieve shared goals.

• Integrity: Upholding ethical standards in all aspects of work, from product development to patient care.

Collaboration Style:

• Cross-functional Integration: The role demands seamless collaboration with Product Management, Engineering, Quality, and Regulatory teams, requiring clear communication and mutual respect for each discipline's contributions.

• Data-Driven Decision Making: Decisions are informed by user research, usability testing data, and product performance metrics, fostering a culture of evidence-based design.

• Constructive Feedback: An environment where constructive feedback is encouraged and valued, both for design work and process improvements, to drive continuous learning and refinement.

📝 Enhancement Note: The culture at Edwards Lifesciences, particularly within a medical device company, is heavily influenced by its mission and the highly regulated nature of its products. The values of patient focus, quality, and collaboration are paramount.

⚡ Challenges & Growth Opportunities

Challenges:

• Balancing Innovation with Regulation: The primary challenge is to drive innovative UX solutions while strictly adhering to stringent medical device regulations (IEC 62366-1, SaMD expectations) and quality management systems.

• Complex User Needs: Designing for clinicians and patients managing critical heart failure conditions requires a deep understanding of complex workflows, diverse user needs, and potential use errors.

• Cross-functional Alignment: Ensuring consistent design vision and execution across multiple engineering and product teams, each with their own priorities and technical constraints.

• Evolving Technology: Keeping pace with advancements in AI and software development while maintaining the rigor required for medical device design.

Learning & Development Opportunities:

• Deepen Regulatory Expertise: Gain advanced knowledge and practical experience in medical device usability engineering and regulatory affairs.

• AI & Data Product Design: Develop specialized skills in designing user experiences for AI-driven features and complex data platforms within healthcare.

• Design System Leadership: Expand expertise in scaling and governing enterprise-level design systems across multiple product lines.

• Mentorship and Strategic Influence: Grow into a recognized leader within the design organization, influencing product strategy and mentoring emerging talent.

📝 Enhancement Note: The challenges presented are inherent to working in the medical device industry. The growth opportunities are tailored to leveraging these challenges as stepping stones for deep specialization and leadership within the company.

💡 Interview Preparation

Strategy Questions:

• "Describe a time you led the design direction for a complex product area. What was your strategy, and how did you ensure consistency across features?" (Focus on setting vision, design systems, and execution.)

• "How do you approach usability engineering for medical devices? Walk us through a formative or summative testing project you led, including the planning, execution, and how you translated findings into design changes and regulatory evidence." (Emphasize IEC 62366-1, test plans, error analysis, and documentation.)

• "How would you influence product strategy when UX recommendations conflict with other stakeholder priorities (e.g., engineering timelines, regulatory constraints)?" (Highlight your communication, negotiation, and data-driven advocacy skills.) Company & Culture Questions:

• "Why are you interested in working for Edwards Lifesciences, specifically within the IHFM business unit?" (Research the company's mission, products, and impact on heart failure patients.)

• "How do you see your role as a Lead Designer contributing to our culture of innovation and patient focus?" (Connect your values and experience to the company's stated mission and values.)

• "Describe your experience working with regulatory affairs and quality assurance teams in a medical device context." (Showcase your understanding of the regulated environment and your ability to collaborate effectively.) Portfolio Presentation Strategy:

• Structure Your Narrative: For each case study, clearly define the problem, your role, the solutions you designed, the user research/usability testing conducted, and the impact/outcomes.

• Quantify Impact: Whenever possible, use data to demonstrate the success of your designs (e.g., reduced error rates, improved task completion times, positive user feedback, successful regulatory submissions).

• Showcase Design Systems: Dedicate a section to your design system work, explaining its structure, governance, and how it ensures consistency and efficiency.

• Highlight HFE Process: Explicitly detail your human factors engineering process, including how you applied IEC 62366-1 and produced necessary documentation.

• Engage Your Audience: Be prepared to answer in-depth questions about your design decisions, your process, and your understanding of the medical device landscape.

📝 Enhancement Note: Interview preparation should strongly emphasize the candidate's ability to navigate the intersection of UX design, human factors engineering, and medical device regulations. The portfolio must serve as concrete evidence of this capability.

📌 Application Steps

To apply for this Lead Designer, UX position:

• Submit your application through the Edwards Lifesciences Careers portal via the provided URL.

• Tailor your Resume: Customize your resume to highlight your 8+ years of design experience, specifically emphasizing leadership in product areas, design system ownership, and extensive usability engineering experience. Integrate keywords like "UX Design," "Human Factors Engineering," "IEC 62366-1," "Figma," "SaMD," and "regulatory compliance."

• Curate Your Portfolio: Ensure your portfolio prominently features 2-3 in-depth case studies showcasing your leadership in design systems and usability engineering for complex products. Be ready to present these with a clear narrative on problem, process, solution, and impact, especially highlighting regulatory aspects.

• Prepare for Technical & Regulatory Discussions: Anticipate questions about your Figma proficiency, design system management, and detailed experience with usability testing methodologies and medical device regulations.

• Research Edwards Lifesciences: Understand the company's mission, its focus on structural heart disease and heart failure management, and its commitment to patient outcomes. Prepare to articulate why you are a good cultural and professional fit.

⚠️ Important Notice: This enhanced job description includes AI-generated insights and operations industry-standard assumptions. All details should be verified directly with the hiring organization before making application decisions.