Director, Systems Engineering - SaMD

Edwards; Irvine (CA); On-site; USD 159,000 - 226,000; Full time

Job summary

Edwards Lifesciences in Irvine is seeking a Director, Systems Engineering - SaMD to own the next‑gen software-enabled capital equipment platform. You will lead cross‑functional teams across hardware, firmware, software, and connectivity, shaping architecture decisions and long‑term platform evolution.

The role is an individual contributor initially, requiring deep technical expertise and executive presence to influence architecture and product strategy while transitioning ownership to Irvine as

Qualifications

• Bachelor's degree in a technical discipline with 12 years of experience or equivalent.
• Extensive hands-on experience commercializing capital equipment or SaMD.
• Deep expertise in software development, embedded systems, and system architecture.
• Proven technical lead, architect, or chief engineer across distributed teams.
• Experience applying Design for Excellence and regulatory practices.
• Experience dealing with IEC 60601, medical devices cybersecurity, and risk management.
• Ability to influence without direct authority across multiple functions.
• Willingness to travel 10–20% (domestic/international).

Responsibilities

• Lead end-to-end integration of a software-enabled capital equipment platform and digital tech.
• Drive architecture decisions, verification strategies, schedules, and program readiness.
• Identify risks and gaps to support product development and commercialization.
• Serve as technical leader and systems architecture authority for the platform.
• Ensure alignment with clinical workflows, regulatory expectations, and cybersecurity.
• Guide cross-functional teams and external partners to maintain technical ownership.
• Communicate recommendations and risks to executives with clear, credible rationale.

Skills

Systems engineering leadership

SaMD

Embedded systems

Architecture & integration

Regulatory & design controls

Executive communication

Hardware-software co-design

Travel readiness

Education

Bachelor’s Degree in Electrical, Computer, Software, Biomedical, or Systems Engineering

Job description

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.

What you’ll need (Required):

• Bachelor’s Degree in Electrical, Computer, Software, Biomedical, Systems Engineering, or a related technical discipline, with 12 years of experience or equivalent work experience based on Edwards criteria
• Significant hands-on experience developing and commercializing capital equipment, Software as a Medical Device (SaMD), reusable electronic platforms, digital health technologies, or other complex software-enabled products.
• Deep technical expertise in one or more of the following: software development and architecture; SaMD; embedded systems and firmware; electronics and electrical systems; systems architecture and integration; or digital and connected technologies.
• Demonstrated experience integrating hardware, firmware, software, user interfaces, connectivity solutions, and associated system components into commercial products.
• Proven experience serving as a technical lead, systems architect, Chief Engineer, systems engineering leader, or comparable technical authority.
• Demonstrated ability to evaluate technical strategies, architecture decisions, development plans, staffing models, schedules, integration approaches, and program risks based on direct product-development experience.
• Demonstrated experience applying Design for Excellence principles, including Design for Reliability, Design for Manufacturability and Assembly, Design for Testability, and Design for Serviceability.
• Demonstrated systems-thinking capability with experience making complex technical and architectural tradeoffs across software, firmware, electronics, reliability, manufacturability, serviceability, quality, cost, and regulatory requirements.
• Experience applying design controls, requirements management, risk management, and verification and validation practices in a regulated environment.
• Working knowledge of IEC 60601 and its application to medical electrical equipment development.
• Demonstrated success influencing multidisciplinary and geographically distributed organizations without direct reporting authority.
• Strong written, verbal, presentation, and executive communication skills.
• Ability to travel approximately 10-20%, including domestic and international travel.

What else we look for (Preferred):

• Master's Degree or equivalent in Electrical, Computer, Software, Biomedical, Systems Engineering, or a related technical discipline, with 10 years of experience
• Medical device development experience, including Class II and/or Class III products.
• Significant experience developing, commercializing, or supporting SaMD, digital health technologies, connected medical systems, cloud-enabled healthcare platforms, or software-enabled clinical products.
• Experience developing capital equipment platforms used in clinical environments.
• Experience with diagnostic, therapeutic, robotic, imaging, patient-monitoring, or other reusable electronic medical technologies.
• Experience leading architecture and integration activities across software, firmware, electronics, and complex electromechanical systems.
• Experience incorporating clinical needs, human factors principles, and user-centered design methodologies into product development.
• Experience supporting technology transfer, technical ownership transitions, or organizational capability-building initiatives.
• Experience working with geographically distributed engineering organizations and external development or manufacturing partners.
• Experience supporting product lifecycle management, including sustaining engineering, software maintenance, platform evolution, cybersecurity updates, serviceability, and end-of-life planning
• Working knowledge of IEC 62304, ISO 14971, medical device cybersecurity, human factors engineering, and regulatory submission support.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
  

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, the base pay range for this position is $159,000 - $226,000 (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.