Jobs at Edwards Lifesciences

Design, develop, test, debug, and deploy scalable cloud-native software in a regulated medical-device environment. Lead architecture, coding, prototyping, APIs, microservices, distributed systems, and full-stack development while applying Generative AI, LLMs, RAG, and AI agents. Provide technical leadership through code reviews, design discussions, mentoring, and cross-functional collaboration with product, clinical, quality, systems, and cybersecurity teams.

Leads architecture and full-stack development for scalable, secure, AI-enabled, cloud-based software supporting regulated medical-device products. The role drives system architecture, roadmaps, software validation, risk management, DevOps, Agile practices, and cross-functional collaboration while mentoring engineering teams. It requires expertise across web, mobile, distributed systems, cloud platforms, generative AI, medical-device software standards, and the full software development lifecycle.

Lead enterprise Developer Experience and cloud architecture strategy across Edwards Lifesciences. Design secure, scalable, compliant cloud solutions; establish developer platforms, DevSecOps capabilities, software delivery standards, infrastructure-as-code practices, and secure SDLC guardrails. Guide disaster recovery, high availability, architecture reviews, cloud governance, vendor relationships, and cross-functional initiatives. Mentor architects and support cloud-based product development in regulated manufacturing and quality environments.

Manage cost center finances, month-end close, reporting, budgeting, forecasting, variance analysis, compliance, and financial planning. Partner with business leaders on resource allocation, strategy execution, special projects, audits, and risk mitigation. Provide financial guidance, develop business-unit reports, support revenue and cost planning, and lead finance-related initiatives while ensuring compliance with GAAP, SOX, SEC, IRS, and Sunshine Act requirements.

Architect and implement secure, scalable Azure cloud solutions for new product development. Lead cloud infrastructure, microservices, IoT, container services, Infrastructure as Code, and DevOps pipeline implementation. Establish configuration management and application deployment practices, conduct code reviews, evaluate technologies, and collaborate with security, operations, privacy, legal, and business stakeholders to ensure compliant, stable, and manageable cloud environments.

Provides executive administrative support to two Senior Vice Presidents by managing calendars, correspondence, presentations, reports, meetings, events, travel, and complex expense reports. Coordinates logistics, screens calls, prepares documents, supports onboarding and communications, and handles confidential information with discretion. The role requires strong organization, communication, problem-solving, relationship management, and advanced Microsoft Office and SAP Concur skills in an on-site, fast-paced environment.

Leads global brand strategy, upstream marketing, product positioning, naming, portfolio architecture, and launch planning for medical device products. Partners with executive, product, clinical, regulatory, legal, medical affairs, and regional teams to drive commercialization and market differentiation. Oversees brand governance, launch frameworks, agencies, budgets, metrics, and cross-functional execution while managing and developing marketing teams.

Leads customer experience and order management for hospital customers and field sales. Supervises, hires, trains, and develops customer service staff; oversees accurate order processing, shipping, billing, returns, complaints, and compliance. Partners cross-functionally to improve processes, maintain inventory reconciliation, resolve escalated issues, and deliver customer service metrics. Ensures adherence to quality systems, FDA requirements, Good Manufacturing Practices, and company procedures.

Leads commercial strategy and sales operations for a medical device business, translating executive priorities into action plans, governance, metrics, and cross-functional initiatives. Supports executive decision-making through briefings, business reviews, analytics, and performance reporting. Owns leadership team governance, operating cadences, strategic planning, risk mitigation, and organizational effectiveness. Partners with commercial operations, analytics, and business intelligence teams to improve execution and business performance.

Provides quality engineering leadership for new product development of transcatheter heart valve devices. Responsibilities include maintaining design controls, risk management, and usability documentation; supporting verification, validation, design transfer, and product launch; investigating quality and compliance issues; optimizing manufacturing and R&D processes using Lean and Six Sigma; and coaching technicians and junior employees.

Leads manufacturing quality assurance for medical devices by investigating CAPAs, nonconformances, and audit observations; optimizing manufacturing and R&D processes using Lean and Six Sigma; maintaining risk management files; creating production documentation; and training or coordinating technicians. Partners across teams to ensure regulatory compliance, improve product quality, reduce manufacturing risk, and support device production and distribution.

Leads complex quality investigations, root-cause analysis, CAPA, risk management, technical studies, and regulatory documentation for medical device manufacturing. Optimizes manufacturing processes using Six Sigma and Lean methods, applies statistical analysis, supports validation and compliance activities, and drives continuous improvement. Partners with cross-functional teams, authors technical reports, and coaches junior employees in a regulated environment.

Lead clinical input and lifecycle management for Class II/III transcatheter heart valve projects. Design and execute pre-clinical and first-in-man evaluations, develop clinical trial strategy and investigator brochures, support site training and regulatory submissions, perform literature reviews and clinical design control documentation, assess field performance and imaging, and guide cross-functional teams on clinical risk assessments and validation activities.

Leads international regulatory affairs for transcatheter mitral and tricuspid medical devices. Responsibilities include preparing and coordinating global regulatory submissions, tracking milestones, developing regulatory strategies, advising product development and manufacturing teams, assessing global requirements, supporting registration and product changes, reviewing labeling, and improving regulatory processes.

Design and develop transcatheter heart valve technologies for aortic regurgitation. Conduct engineering studies, verification testing, data analysis, prototyping, and design documentation. Collaborate with clinical, manufacturing, quality, regulatory, marketing, and supplier teams throughout the product development lifecycle. Support design controls, risk management, component specifications, supplier development, and laboratory technician guidance.

Leads financial planning, forecasting, reporting, and decision support for the Global Operations and Quality Worldwide Engineering organization. Coordinates annual operating plans, strategic planning, monthly forecasts, management presentations, headcount reporting, and freight and distribution expense modeling. Partners with stakeholders to identify risks, improve processes, ensure regional consistency, and provide actionable financial insights. Supports cross-functional teams with ad hoc analyses and business requests.

The EDI Operations Analyst serves as the subject matter expert for electronic customer ordering, EDI connectivity, GHX integration, and hospital trading partner onboarding. Responsibilities include gathering requirements, troubleshooting transaction and order issues, analyzing process metrics, testing system changes, documenting workflows, coordinating stakeholders, training users, and supporting continuous improvement to increase electronic order adoption and reduce manual processing.

Leads enterprise lifecycle management programs for commercialized medical device portfolios, including supplier changes, manufacturing transfers, market launches, process equipment implementation, and product updates. Coordinates Manufacturing, Supply Chain, Quality, Regulatory, Engineering, Finance, and external manufacturers to manage risk, maintain compliance, ensure business continuity, and sustain global product supply. Provides technical engineering guidance, tracks performance metrics, manages budgets, and escalates program risks.

Leads AI-enabled transformation across clinical development and regulatory operations, including trial acceleration, safety workflows, regulatory submissions, and clinical technology adoption. Partners with Clinical Affairs, Biometrics, Safety, Regulatory, product, data, and engineering leaders to improve cycle time, quality, productivity, and workflow adoption. Requires substantial clinical operations or regulatory experience, database lock and FDA submission experience, and AI-driven pharmacovigilance expertise.

Leads the design, governance, and operation of secure, reusable enterprise AI platforms. Owns AI architecture, gateway and model routing, observability, production reliability, vendor rationalization, FinOps, platform roadmaps, and developer experience. Chairs the AI Center of Excellence and builds delivery pods through shared-capacity agreements with IT. Provides hands-on technical leadership, manages teams, and establishes standards across AI initiatives.