Director, SaMD Systems Engineering - Capital Equipment

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

Job summary

Edwards Lifesciences is seeking a Director, Systems Engineering - SaMD within the Transcatheter Mitral and Tricuspid Therapies (TMTT) organization. This role will own the technical direction of a software-enabled capital equipment platform and related digital technologies across hardware, firmware, software, and connectivity.

As an individual contributor initially, you will provide architecture oversight, drive risk management, and align designs with regulatory requirements, DFx principles, and

Qualifications

• Bachelor's Degree with 12 years of experience or equivalent.
• Hands-on experience developing and commercializing capital equipment, SaMD, or software-enabled products.
• Deep technical expertise in software development and architecture; embedded systems and firmware.
• Experience integrating hardware, firmware, software, UI, connectivity into commercial products.
• Experience as technical lead or architect and guiding complex architectures.
• Experience applying Design for Excellence (DFX) principles.
• Knowledge of design controls, risk management, and verification in regulated environments.
• Working knowledge of IEC 60601 and regulatory expectations.
• Ability to travel 10–20%.

Responsibilities

• Lead end-to-end integration of a software-enabled capital equipment platform and digital technologies.
• Drive technical execution across the product lifecycle with architecture reviews and schedules.
• Identify and resolve system-level issues, risks, and gaps for development and commercialization.
• Serve as technical leader and architecture authority guiding design decisions and long-term evolution.
• Ensure decisions align with user needs, regulatory expectations, cybersecurity, and business objectives.
• Apply DFx principles balancing performance, reliability, manufacturability, serviceability, cost.
• Coordinate knowledge transfer across distributed teams and partners.
• Influence direction across Engineering, Quality, Regulatory, Manufacturing, and Programs.
• Communicate technical recommendations and program health to executives.

Skills

SaMD development

Embedded systems

Systems architecture

Regulatory compliance

IEC 60601 knowledge

Executive communication

Technical leadership

Education

Bachelor's Degree in Electrical, Computer, Software, Biomedical, Systems Engineering

Master's Degree (preferred)

Job description

Edwards Lifesciences is seeking a Director, Systems Engineering - SaMD within the Transcatheter Mitral and Tricuspid Therapies (TMTT) organization. This role will own the technical direction of a software-enabled capital equipment platform and related digital technologies across hardware, firmware, software, and connectivity.

As an individual contributor initially, you will provide architecture oversight, drive risk management, and align designs with regulatory requirements, DFx principles, and