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USA - California – Irvine, United States of America
Onsite
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.
Strategy and technical direction
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.
Hands-on technical leadership
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.
Organization and talent
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.
Quality, regulatory, and performance
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.
Communication and influence
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.
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.
Deep experience leading agile software delivery at scale, including establishing and scaling Scrum and other agile practices, ceremonies, and delivery cadences across multiple teams.
Working knowledge of mobile (iOS and Android) development across native (Swift / SwiftUI, Kotlin / Jetpack Compose) and cross-platform frameworks (React Native, Flutter), sufficient to guide platform and architecture decisions for the mobile estate.
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.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $191,000 to $271,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
