Many structural heart patients experience heart failure with limited treatment options. The Implantable Heart Failure Management (IHFM) team, part of the AI, Product and Platforms organization at Edwards Lifesciences, is focused on addressing these unmet needs through pioneering technology that enables earlier, more targeted therapeutic intervention. Our work helps clinicians deliver better care and supports patients in living longer, healthier lives.
As Director, Software Systems, Process & Delivery, you will lead the sub-function responsible for how IHFM’s regulated software and data products are planned, documented, orchestrated, and delivered. Through managers and senior individual contributors, you will own delivery execution, release readiness, process and traceability systems, and design control discipline that keeps products audit-ready and aligned to patient, clinician, quality, and regulatory needs.
Based in Irvine, California, this role is part of a high-impact medtech innovation hub in Orange County, where you will collaborate in person with cross-functional teams to shape patient-focused technology.
Drive delivery execution and predictability:
- Own sprint planning, execution, and delivery across software and data teams, driving clear commitments, predictable outcomes, and fast issue resolution.
- Manage dependencies, sequencing, and delivery trade-offs across complex initiatives.
Own release orchestration and readiness:
- Lead release orchestration, environment promotion, and go-live readiness across the sub-function.
- Set release readiness gates, including design freeze, verification-complete, validation-complete, risk assessments, and post-release monitoring.
- Partner with Test and DevSecOps teams to incorporate their evidence and security gates into release readiness decisions.
Architect scalable process and traceability systems:
- Establish and continuously improve the end-to-end product development process, from intake through release, so delivery remains consistent, compliant, and efficient.
- Own the SSDLC, traceability model, and engineering tool workflows that enable teams to operate with rigor and clarity.
Own design control and audit readiness:
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- Lead design control process discipline across the sub-function, supporting alignment with 21 CFR 820.30, IEC 62304, ISO 13485, and ISO 14971.
- Ensure delivery, process, and documentation artifacts are audit-ready and inspection-ready in partnership with Quality and Regulatory teams.
Lead and grow the team:
- Lead the sub-function, or a major portion of it, through managers and senior individual contributors.
- Build leadership capability across the team through hiring, performance management, coaching, and talent strategy.
Drive metrics and continuous improvement:
- Define and monitor delivery metrics, including predictability, lead time, and throughput, and use insights to improve execution and outcomes.
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.
- Ability to work onsite in Irvine, California. Relocation is not provided for this role; only candidates within a 50-mile radius of Irvine will be considered.
What else we look for (Preferred):
- 12+ years of progressive experience leading delivery, process, or software programs of increasing complexity, including experience managing managers.
- Deep expertise in regulated software processes, SSDLC, traceability, and release readiness.
- Working knowledge of design controls, including 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 support release readiness, with the ability to partner effectively with those teams.
- Strong partnership with Product Management on prioritization, sequencing, and trade-off decisions.
- 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 or FDA Case for Quality experience.
- Data-driven mindset, strong communication and leadership skills, and attention to detail while maintaining 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.
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