Director, Innovation (Digital Early… at Edwards… · Californi…

How you will make an impact:

This is an exciting opportunity to join a team identifying unmet patient needs and boldly designing a new category of digital products for Edwards Lifesciences. Edwards’ Advanced Innovation & Technology team is deeply dedicated to solving the complex challenges in the broader structural heart field in order to transform treatment and significantly improve patients’ lives around the world.

Edwards Lifesciences Advanced Innovation & Technology (AI&T) division has a unique opportunity for a Director, Innovation (Digital Early Incubation, Technical Program Management) to join our growing team, to be part of the team driving a new digital innovation portfolio for the future of Edwards Lifesciences. Be part of the team to build and implement the strategy for needs driven innovation within the AI&T incubator driving a multidisciplinary project team to identify opportunities. This highly collaborative role will partner with multiple teams that compete on numerous projects based on value proposition and feasibility of new products.

The Director, Innovation (Digital Early Incubation, Technical Program Management) will contribute to the planning, execution, and delivery of novel digital and software-based solutions within Edwards Lifesciences’ early-stage incubator, guiding digital product concepts from ambiguity to architectural clarity and product feasibility. This role will be pivotal in driving cross-functional alignment, managing technical complexity, and ensuring timely delivery of innovative digital health products that complement Edwards’ cardiovascular devices portfolio.

Key Responsibilities:

• Deeply understand clinical management paradigms, anatomy, and pathophysiology to define clinical unmet needs for various patient segments along the care pathway
• Actively contribute to generation of new digital product concepts, prioritization/screening of concepts, and de-risking through data-driven methods
• Robustly characterize minimum viable product with a strong understanding of market adoption criteria, define strategies for demonstrating proof-of-concept, and chart a detailed plan for sufficiently de-risking and defining the digital product concept and achieving readiness to enter formal product development under design control (SaMD)
• Develop, plan and prioritize impactful projects and activities based on value proposition, clinical needs driven innovation, and feasibility of new digital products, with accountability for successful completion of all project deliverables
• Partner with internal technology and business leaders to identify, develop and execute new whitespace product opportunities
• Manage multiple concurrent early-stage software development programs, ensuring delivery on time and within scope
• Identify project and schedule risks and dependencies, developing complex mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups.
• Collaborate with product manager, UX/UI designer, and software engineers on requirements, roadmaps, and execution of project deliverables
• Communicate program status, risks, and dependencies to leadership and cross-functional stakeholders
• Maintain detailed program documentation, including project plans, timelines, dependencies, executive readouts, and decisions logs with rationale
• Serve as visionary for software architecture of early-stage digital concepts, factoring in anticipated risks and translatability (e.g. integration feasibility, system-level impact and scalability) to go from early prototype phase to builds that will be validated and shipped to clinical end-users. Define transition plans between the upstream/early-stage and downstream/PDP phases
• Implement and champion agile methodologies and lean startup principles for rapid prototyping and iteration. Balance speed, learning, and rigor, ensuring concept work progresses while preserving optionality.
• Understand and influence processes for data ingestion, normalization, and structuring from multiple sources (device, EMR, cloud platforms)
• Identify opportunities for leveraging AI, cloud, and data analytics in digital health solutions

What you'll need (Required):

• Bachelor's Degree or Equivalent in Engineering, Science or Business Administration with 12 years of relevant experience -OR- Master's Degree or equivalent with 10 years of relevant experience -OR- Ph.D. or equivalent with 8 years of relevant experience (Degree in Computer Science strongly preferred)
• Strong track record of technical program management for new early-stage or concept-stage software/digital product development initiatives in the medtech domain, with proven ability to coordinate multidisciplinary technical teams and manage dependencies
• Proficiency with project management and collaboration tools (e.g. JIRA, Confluence)
• Experience developing digital products/services spanning multiple hardware platforms (e.g. desktop, tablet, phone)
• Strong understanding of software development lifecycle (SDLC), agile frameworks, cloud-based architectures, system requirements, and technical trade studies
• Exceptional organizational skills with the ability to manage multiple priorities simultaneously
• Experience working in both the medical device (or life sciences) industry and digital/tech industry
• Familiarity with implantable medical devices
• Experience in roles requiring knowledge of a domain of human anatomy and physiology (ideally cardiovascular)
• Excellent communication, leadership, and stakeholder management skills
• Strong presentation skills, adaptable to various audiences ranging from design reviews to executive-level forums

What else we look for (Preferred):

• Experience working with remote software engineering teams (i.e. international)
• Ability to quickly evaluate solution viability, courage to fail fast and learn from mistakes
• Practical knowledge of clinical trials and biostatistics
• Experience with Software as a Medical Device (SaMD) and regulatory compliance (FDA, ISO 13485, IEC 62304)
• Understanding of business strategy and competitive landscape in the medical device / medtech industry
• Technical background in software engineering or systems architecture, with prior experience as a software engineer or hands-on coding background (e.g. Python, JavaScript), enabling effective collaboration with development teams
• Experience with product use cases involving medical imaging (e.g. CT, MRI, echo/ultrasound) or image processing
• PMP or other formal project management certification (e.g. Agile)
• Familiarity with cybersecurity, data privacy (HIPAA), interoperability standards (FHIR, HL7), and hospital integrations (e.g. cath lab/OR)
• Experience with data pipelines, ETL processes, and data structuring for digital health or software products
• Exposure to AI/ML workflows and how structured data support predictive modeling
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Data-driven but ability to make decisions based on imperfect information
• Demonstrated ability to develop relationships to drive alignment of objectives
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast-paced environment
• Ability to represent leadership on projects within multiple areas, interfacing with project managers, team and middle to senior management
• Ability to consult in a project setting within multiple areas, interfacing with low to middle management
• Adhere to all EHS rules and requirements 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
• Proficient in Microsoft Office Suite

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 $170,000 to $241,000 (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.