Director, SaMD Systems Engineering – Medical Devices

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

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