Director, Software Systems, Process and Delivery (Irvine)

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team, part of the 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.

At Edwards Lifesciences, the IHFM AI, Product and Platforms organization designs and builds the software and data products that clinicians and patients depend on. As a Director, you lead the Software Systems, Process, and Delivery sub-function, or a major portion of it, through a team of managers and senior individual contributors. You own how IHFM's regulated software and data products are architected for rigor, documented, and delivered: the process and traceability systems, the sprint execution and release readiness, and the design control discipline that keeps it all audit ready. Test strategy and DevSecOps sit with separate teams; you own the sprint execution, release orchestration, and readiness gates their evidence flows into, not those disciplines themselves.

Based in Irvine, CA, you'll join a high-impact medtech innovation hub in the heart of Orange County, collaborating in person with cross-functional teams to shape patient-focused technology.

How you'll make an impact

Drive delivery execution and predictability

• Own sprint planning, execution, and delivery across the sub-function's software and data teams, driving clear commitments, predictable outcomes, and fast issue resolution.
• Manage dependencies, sequencing, and delivery trade-offs across initiatives.

Own release orchestration and readiness

• Lead release orchestration, environment promotion, and go-live readiness across the sub-function.
• Set the release readiness gates (design freeze, verification-complete, validation-complete), risk assessments, and post-release monitoring, drawing test evidence and security gates from the Test and DevSecOps teams.

Architect scalable process and traceability systems

• Establish and continuously improve the end-to-end product development process, from intake through release, so delivery stays consistent, compliant, and efficient.
• Own the SSDLC, traceability model, and engineering tool workflows the teams run on.

Own design control and audit readiness

• Own the design control process discipline (21 CFR 820.30, IEC 62304, ISO 13485, ISO 14971), keeping it well-designed, resourced, and audit-ready across the sub-function.
• Provide delivery, process, and documentation artifacts that stand up in audits and inspections, partnering closely with Quality and Regulatory.

Lead and grow the teams

• Lead the sub-function, or a major portion of it, through managers and senior individual contributors, and build the leadership bench.
• Own hiring, performance, and talent strategy.

Drive metrics and continuous improvement

• Define and monitor delivery metrics such as predictability, lead time, and throughput, and use them to sharpen execution.

What you'll need (Required):

• Bachelor’s or Master’s degree in a related field, or equivalent work experience based on Edwards criteria
• Experience leading Agile delivery execution across software, data, or technology teams
• Experience with regulated product development, software delivery, platforms, or data systems
• Relocation is not provided for this role. Only candidates within a 50-mile radius of Irvine, California will be considered.

What else we look for (Preferred):

• 12+ years of hands‑on experience leading delivery, process, or software programs of increasing complexity, including managing managers.
• Deep expertise in regulated software process, the SSDLC, traceability, and release readiness.
• Working command of design controls (21 CFR 820.30), IEC 62304, ISO 13485, and ISO 14971.
• Proven ownership of end-to-end software and data delivery across multi-team environments, with a track record of predictable Agile execution.
• Experience building scalable delivery and development processes and driving organizational change.
• Familiarity with how test automation, CI/CD, and DevSecOps practices feed release readiness, sufficient to partner effectively with those teams.
• Strong partnership with Product Management on prioritization and trade-offs.
• Ability to influence engineering, data, business, and executive stakeholders in a matrixed environment.
• Certified Scrum Professional (CSP), Advanced Certified ScrumMaster (A‑CSM), PMI‑PMP, or similar certification.
• SaMD pre‑market submission and FDA Case for Quality experience.
• Data‑driven mindset, excellent communication and leadership skills, and strict attention to detail while keeping focus on delivery outcomes.
• Ability to lead meetings with internal and external stakeholders, including vendors and partners, to drive alignment and decisions.

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 $159,000 to $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.

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.