Senior Designer, UX

📍 Job Overview

Job Title: Senior Designer, UX

Company: Edwards Lifesciences

Location: Irvine, California, United States

Job Type: Full time

Category: User Experience (UX) Design / Human Factors Engineering

Date Posted: 2026-09-02

Experience Level: 5-10 Years

Remote Status: On-site

🚀 Role Summary

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

• Lead the development and maintenance of design systems, including components, patterns, and accessibility standards, to ensure consistency and usability across IHFM products.

• Spearhead usability engineering activities, encompassing planning and execution of formative and summative usability testing and use-error analysis to support regulatory submissions (IEC 62366-1).

• Act as a key Human Factors Engineering (HFE) contributor for Software as a Medical Device (SaMD), collaborating closely with cross-functional teams to ensure safe and effective product design.

📝 Enhancement Note: This role is positioned as an entry-level Subject Matter Expert (SME) within the Human Factors Engineering (HFE) track, requiring a blend of advanced design craft, technical acumen, and regulatory understanding. The focus on SaMD and IEC 62366-1 compliance indicates a highly regulated environment where design directly impacts patient safety and regulatory approval.

📈 Primary Responsibilities

• Define and champion the design vision and strategy for a specific product domain within the IHFM portfolio, ensuring alignment with user needs and business objectives.

• Own and evolve the design systems for the assigned product area, including establishing contribution guidelines, maintaining component libraries, and enforcing accessibility standards.

• Plan, execute, and analyze usability testing (formative and summative) in accordance with IEC 62366-1 standards, translating findings into actionable design improvements and contributing to the usability engineering file.

• Serve as the primary Human Factors Engineering representative on product development teams, providing expert guidance on user interface design, interaction design, and risk mitigation strategies related to human use.

• Collaborate with Product Management, Software Engineering, Data Engineering, Quality Assurance, and Regulatory Affairs to influence product roadmaps, prioritize features, and ensure successful product launches that meet both user and regulatory requirements.

• Mentor junior designers and contribute to the overall growth and development of the design practice within the organization.

• Conduct use-error analysis and risk assessments, identifying potential hazards associated with device use and recommending design interventions to minimize risks.

• Ensure that all design outputs adhere to relevant medical device regulations and quality management system requirements.

📝 Enhancement Note: The emphasis on "leading design systems work" and "leading usability engineering activities" suggests a senior individual contributor role with significant ownership and influence over critical design processes. The requirement to support regulatory submissions under IEC 62366-1 highlights the critical nature of this role in a regulated medical device environment.

🎓 Skills & Qualifications

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

Experience: Minimum of five (5) years of progressive design experience, with a proven track record in leading the design of a major product area, or equivalent work experience as defined by Edwards Lifesciences.

Required Skills:

• Deep proficiency with design and prototyping tools, specifically Figma, for creating high-fidelity interfaces and design systems.

• Extensive experience in planning, executing, and analyzing formative and summative usability testing for complex software applications.

• Strong understanding and practical application of Human Factors Engineering (HFE) principles and methodologies in software development.

• Proven experience in developing and managing design systems, including component libraries, pattern definition, and accessibility standards.

• Familiarity with IEC 62366-1 standards for the application of usability engineering to medical devices.

• Experience with research and usability toolsets such as Dovetail and/or UserTesting.

• Ability to effectively communicate design rationale and influence product strategy with cross-functional teams.

• Demonstrated ability to mentor designers and contribute to team growth.

• Must reside within a 50-mile radius of Irvine, CA, as this is an on-site role. Preferred Skills:

• Direct experience with usability engineering for medical devices, including contributions to a Usability Engineering File or Design History File (DHF).

• Familiarity with Software as a Medical Device (SaMD) regulatory expectations and associated quality management systems.

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

• Working knowledge of relevant technical stacks and interoperability standards such as Android, iOS, React, Angular, .NET Core, REST, Databricks, Snowflake, HL7, FHIR, and IHE.

• Ability to communicate design rationale effectively to senior stakeholders and drive cross-functional alignment.

• Proven track record of shipping high-quality designs that demonstrably improve user outcomes through research and iteration.

📝 Enhancement Note: The explicit mention of "equivalent work experience based on Edwards criteria" suggests that while a Bachelor's degree is preferred, extensive relevant experience could be considered. The strong emphasis on Figma, Dovetail, and UserTesting points to a specific toolchain that candidates should be familiar with.

📊 Process & Systems Portfolio Requirements

Portfolio Essentials:

• Showcase a minimum of 2-3 significant product design projects, with at least one demonstrating end-to-end ownership of a product area or complex feature set.

• Clearly articulate your role and contributions in each project, emphasizing design direction, system ownership, and usability engineering efforts.

• Include detailed case studies that highlight your process, from user research and ideation through to final design implementation and iteration.

• Demonstrate the application of design systems and accessibility standards in your work, providing examples of components, patterns, and how they ensure consistency and inclusivity.

• Present evidence of your usability testing process, including planning, methodology, participant recruitment, data analysis, and how insights informed design decisions and improved user outcomes. Process Documentation:

• Detail your approach to defining and evolving design systems, including how you manage components, establish patterns, and ensure scalability and maintainability.

• Illustrate your methodology for conducting usability engineering activities, specifically referencing formative and summative testing, use-error analysis, and the creation of documentation for regulatory submissions.

• Provide examples of how you collaborate with cross-functional teams (e.g., Product Management, Engineering, Quality, Regulatory) to integrate design and HFE into the product development lifecycle.

• Showcase your ability to document design rationale and technical specifications for handoff to development teams, ensuring accurate implementation of designs.

📝 Enhancement Note: Given the medical device context, the portfolio should heavily emphasize a structured, evidence-based design process, with a clear focus on how design decisions and usability efforts directly contribute to patient safety and regulatory compliance. Demonstrating experience with documentation for regulatory bodies is crucial.

💵 Compensation & Benefits

Salary Range: $108,000 - $153,000 USD per year (for highly experienced candidates in California).

Benefits:

• Competitive salaries that reflect experience and market value.

• Performance-based incentives designed to reward contributions and achievements.

• A wide variety of benefits programs tailored to meet diverse individual and family needs, which may include health insurance, retirement plans, paid time off, and professional development opportunities.

Working Hours: Standard full-time work schedule, likely around 40 hours per week, with potential for flexibility depending on project needs and team collaboration.

📝 Enhancement Note: The provided salary range is specifically for California and is presented as a "highly experienced" benchmark. The actual salary will be determined by a combination of the candidate's qualifications, education, and prior experience. The benefits are described broadly, suggesting a comprehensive package typical for a large, established medical technology company.

🎯 Team & Company Context

🏢 Company Culture

Industry: Medical Devices / Healthcare Technology. Edwards Lifesciences is a global leader in patient-focused medical innovations, particularly in structural heart disease and critical care monitoring. The IHFM business specifically focuses on pioneering AI and data-driven solutions for heart failure management.

Company Size: Edwards Lifesciences is a large, established public company (likely thousands of employees globally). This size implies structured processes, clear career paths, and significant resources, but also potentially a more formal work environment.

Founded: Edwards Lifesciences was founded in 1958, indicating a long history of innovation and stability in the medical technology sector. This longevity suggests a company with deep expertise and a strong commitment to its mission.

Team Structure:

• The IHFM AI, Product and Platforms organization is likely a significant division within Edwards Lifesciences, comprising specialized teams in AI, product development, and platform engineering.

• The UX Design team operates within this organization, likely reporting into a design leadership role, and collaborates closely with Product Management, Software Engineering, Data Engineering, Quality, and Regulatory Affairs.

• There is a clear emphasis on cross-functional collaboration, with designers influencing product strategy alongside technical and business leaders. Methodology:

• Emphasis on data-driven product development, leveraging AI and advanced analytics to improve patient outcomes.

• A structured approach to product design and development, adhering to rigorous medical device regulatory standards (e.g., IEC 62366-1, SaMD).

• Focus on user-centric design, ensuring that products are safe, effective, and intuitive for clinicians and patients.

• Agile methodologies are likely employed for software development, with design integrated into iterative cycles.

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

📝 Enhancement Note: The company's mission to "help patients live longer and healthier lives" is a strong cultural driver. The focus on AI and pioneering technology within a regulated medical device framework suggests a culture that values innovation, scientific rigor, and a deep commitment to patient well-being.

📈 Career & Growth Analysis

Operations Career Level: This role is classified as a Senior Designer, UX, and is positioned at the entry-level of the Subject Matter Expert (SME) track. This signifies a role for an experienced professional who is becoming a recognized expert in their domain (UX Design and Human Factors Engineering) within the company. It involves leading design direction, owning critical processes, and influencing product strategy, rather than managing people directly.

Reporting Structure: The Senior UX Designer will likely report to a Design Lead, Director of UX, or Head of Product Design within the IHFM AI, Product and Platforms organization. They will work closely with cross-functional leaders in Product Management, Engineering, Quality, and Regulatory.

Operations Impact: The UX Designer's work directly impacts the safety, efficacy, and usability of critical medical devices, influencing patient outcomes and the company's ability to achieve regulatory approval and market success. Their design decisions are integral to the overall product strategy and the company's mission of improving patient lives.

Growth Opportunities:

• Specialization: Deepen expertise in Human Factors Engineering for medical devices, SaMD regulations, and advanced UX design methodologies.

• Leadership: Progress into a Lead Designer role, a Principal Designer, or potentially a management track (e.g., Design Manager) within the UX or HFE domain.

• Cross-Functional Expertise: Develop broader understanding of product management, software engineering, and regulatory affairs, enabling more strategic influence.

• Mentorship: Continue to mentor junior designers, contributing to the development of the design team and establishing best practices.

• Industry Contribution: Potentially contribute to industry standards or publications related to UX and HFE in medical devices.

📝 Enhancement Note: The SME track indicates a career path focused on deep technical and craft expertise, offering an alternative to traditional people management roles for senior individual contributors. This is a valuable trajectory for operations professionals who want to remain hands-on with complex problem-solving.

🌐 Work Environment

Office Type: This is an on-site role, indicating a traditional office-based work environment within Edwards Lifesciences' facilities in Irvine, CA.

Office Location(s): The primary work location is Irvine, California. Candidates must reside within a 50-mile radius of Irvine to be considered. Specific details about the office layout, amenities, and accessibility would be available upon inquiry or during the interview process.

Workspace Context:

• The workspace is likely designed to foster collaboration among cross-functional teams, including designers, engineers, product managers, and quality/regulatory personnel.

• Access to necessary design tools, software, and potentially specialized usability testing labs or equipment would be provided.

• The environment is expected to be professional and focused, given the nature of medical device development and regulatory compliance.

Work Schedule: A standard 40-hour work week is anticipated, with core business hours in the Pacific Time Zone. While an on-site role, there might be some flexibility in daily start/end times, subject to team needs and project deadlines.

📝 Enhancement Note: The "on-site" requirement and the 50-mile radius stipulation are critical for candidates to note, as relocation assistance is not provided. This suggests a strong emphasis on in-person collaboration and team integration.

📄 Application & Portfolio Review Process

Interview Process:

• Initial Screening: A recruiter or hiring manager will review applications and