Director, Software Systems, Process and Delivery

Edwards Lifesciences•Irvine, CA

1d•$159,000 - $226,000•Onsite

About The Position

The Implantable Heart Failure Management (IHFM) team, part of the AI, Product and Platforms organization at Edwards Lifesciences, is focused on addressing unmet needs in structural heart patients with limited treatment options through pioneering technology. This role will lead the sub-function responsible for how IHFM’s regulated software and data products are planned, documented, orchestrated, and delivered. The position owns delivery execution, release readiness, process and traceability systems, and design control discipline to ensure products are audit-ready and aligned with patient, clinician, quality, and regulatory needs. This role is based in Irvine, California, and involves in-person collaboration with cross-functional teams to shape patient-focused technology.

Requirements

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.
Must reside within a 50-mile radius of Irvine, CA.

Nice To Haves

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.

Responsibilities

Drive delivery execution and predictability across software and data teams, ensuring clear commitments, predictable outcomes, and fast issue resolution.
Manage dependencies, sequencing, and delivery trade-offs across complex initiatives.
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.
Establish and continuously improve the end-to-end product development process, from intake through release, ensuring consistent, compliant, and efficient delivery.
Own the SSDLC, traceability model, and engineering tool workflows.
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 the sub-function through managers and senior individual contributors.
Build leadership capability across the team through hiring, performance management, coaching, and talent strategy.
Define and monitor delivery metrics, including predictability, lead time, and throughput, and use insights to improve execution and outcomes.
Lead meetings with internal and external stakeholders, including vendors and partners, to drive alignment and decisions.