Director, Systems Engineering SaMD

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 patients unmet clinical needs. Its 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 youll need (Required):

• Bachelors 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 1020% including domestic and international travel.

What else we look for (Preferred):

• Masters 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 $159000 - $226000 (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.