Edwards Lifesciences

• Establish and lead the enterprise BPM capability, including vision, operating model, governance, standards, and success metrics across business domains (30%). • Define, maintain, and govern enterprise BPMN standards and process architecture, ensuring consistency, scalability, and audit readiness (25%). • Partner with business domain SMEs and process owners to lead process discovery, validation, and target-state definition, remaining process-agnostic while ensuring enterprise alignment (20%). • Lead process intelligence and analytics enablement, including KPI frameworks, value realization tracking, and engagement with process mining platforms (e.g., Celonis) to surface how processes operate versus designed intent (15%). • Facilitate structured process discovery sessions to map current-state workflows, uncover exceptions and variations, and validate findings with cross-functional stakeholders.

Title: Sr Specialist, Clinical Imaging, TMTT (US Remote) Location: USA-California-Remote Job Description: Full time job requisition id Req-48126 Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. As a Sr Specialist, Clinical Imaging you will conduct analysis of multiple imaging modalities for the case planning team for the Transcatheter Mitral & Tricuspid Therapies (TMTT) US commercial team. This position will play a key role in supporting the case planning needs for the SAPIEN M3 Transcatheter Mitral Valve Replacement Therapy US field team for achievement of exceptional procedural outcomes. Role is open to US based, remote candidates. Occasional travel for training and department meetings at Irvine CA corporate campus required. How you’ll make an impact: - Analyze 3D Computed Tomography reconstruction for cases for BU case planning to determine measurement suitability for anatomy for BU implantation. Provide comprehensive imaging report for case planning purposes. - Perform CT reconstructions that are beyond the scope or experience of the field team in support of case planning to optimize patient outcomes. - Responsible for tracking case planning process through multiple technical platforms in partnership with the analyst, field team, sales operations, information technology, and external stakeholders. - Train field team and/or health care providers on CT and other imaging modality acquisition and interpretation and provide guidance on case planning strategy execution. - Responsible for entering data for case planning measurements into CRM software. - Identify gaps and provide recommendations on CT acquisition process improvements. - Design and develop training content relevant to image analysis for stakeholders (e.g., field support team and/or health care professionals). - Assist in the execution of quality assurance processes and other process improvements for team members (e.g. field teams). - Participate in knowledge transfer sessions with field team to review challenging cases to identify process improvement optimization. What you’ll need (required): - Bachelor's Degree or Associate’s Degree in related field or equivalent work experience based on Edwards criteria required - Minimum 5 years’ experience of previous in-hospital clinical echocardiographic experience required - Certification in relevant imaging modality certification (e.g., American Registry of Radiologic Technologists ARRT; RDCS or RCS) preferred - Able to travel up to 10% What else we look for (preferred): - Advanced knowledge of relevant imaging equipment operation (e.g. 2D or 3D TTE/TEE/ICE, CT, MRI, etc.) - Substantial knowledge and understanding of principles, theories, and concepts relevant to cardiovascular imaging - Proficient in Microsoft Office Suite applications (Outlook, Word, Excel, PowerPoint etc) - Experience with imaging analysis software (TomTec, Xcelera, 3Mensio, TomTec, Vitrea, Circle VI, etc.) highly preferred - Demonstrates professional written and verbal communication skills - Able to effectively guide and instruct other imaging specialists in clinical settings on effective imaging equipment operation - Strong diplomacy, influencing and relationship management skills - Proven abilities in problem-solving, critical thinking and strict attention to detail - Trained or knowledgeable in relevant imaging equipment operation - Thrives in a team environment, fostering collaboration between inter-departmental teams, HCPs and KOLs. - Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines - Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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 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, the base pay range for this position is $108,000 to $154,000 (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.

• Own the complete screening workflow from initial imaging submission to delivery of final results to clinical sites. • Ensure timely progression of each patient through all workflow steps. • Serve as the first point of contact for sites regarding screening status, system issues, and any questions related to the screening process. • Maintain accurate communication records and ensure exceptional service to clinical sites. • Manage and administer digital platforms supporting the screening workflow, including: imaging submission platforms, Salesforce, Monday.com and additional internal workflow and documentation systems. • Provide system access to physicians and internal team members following governance standards. • Troubleshoot issues, open service tickets, follow up on resolutions, and escalate when needed. • Maintain data accuracy and completeness across all systems. • Work closely with the Clinical Imaging Screening Specialist on daily screening operations, escalations, and clinical/imaging related items. • Collaborate with internal partners (Imaging, Clinical Affairs, Data Management, Operations, Commercial team) to support efficient, compliant workflows. • Assist with updating or drafting of training materials, SOPs, and process documentation as needed. • Oversee dashboards and reporting tools that track screening activity, site performance, turnaround times, and workflow trends. • Provide routine and ad-hoc data summaries, metrics, and insights to internal stakeholders. • Identify workflow bottlenecks or improvement opportunities using data-driven analysis. • Demonstrates strong digital agility with the ability to quickly learn, adopt, and administer new applications and workflow tools. • Proactively identifies and implements technology-driven opportunities to streamline workflows, improve efficiency, and reduce manual effort. • Brings forward practical, data-driven ideas and adapts confidently in evolving digital environments. • Support continuous improvement initiatives within the TMTT Screening Team.

Role Description Innovation starts from the heart. At Edwards Lifesciences, we’re dedicated to developing ground-breaking technologies with a genuine impact on patients’ lives. At the core of this commitment is our investment in cutting-edge information technology. This supports our innovation and collaboration on a global scale, enabling our diverse teams to optimize both efficiency and success. As part of our IT team, your expertise and commitment will help facilitate our patient-focused mission by developing and enhancing technological solutions. Develop, create, and implement IT processes and policies as it relates to Change Management/Control, Compliance, Governance, and Vendor Management. Analyze and determine the appropriate course of action for non-compliance/conformance deviations. The candidate will be responsible for feature development and maintaining the code base related to Edwards’ proprietary EW1 Hybrid Web application, a mission-critical app used by our field sales teams to further our ability to deliver devices that maximize our patient’s recovery and quality of life. You will be tasked with using Angular best practices to create a streamlined user experience in a complex application, while ensuring quality control standards. The application includes mobile, desktop, data architecture, and Salesforce integrations. How you'll make an impact: - Hands-on Angular development using modern UI/UX and Angular best practices according to requirements and test. - Build repeatable and executable design strategies and patterns for tactical initiatives in collaboration with project teams. - Provide design and architecture recommendations to project teams to execute medium to large sized initiatives or programs. - Lead project development teams through execution of best practices in software development, mentoring other team members. - Plan projects and activities with accountability for successful completion within scope and ensuring that project deliverables are consistent with architecture, quality, security policies. - Oversee the efforts to determine operational feasibility by evaluating analysis, problem definition, requirements, solution development, and proposed solutions. - Engineer software code, ETL code, or web applications solutions by using application development tools. - Lead the development of documentation, flowcharts, layouts, diagrams, charts, code comments and clear code on complex issues. - Provide technical guidance and lead the improvement of operations by conducting systems analysis; recommending changes in policies and procedures. - Keep abreast of technical innovation by studying state-of-the-art development tools, programming techniques, and computing equipment; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations. - Determine and lead the design of system specifications, standards, and programming: Provide technical guidance to team members. - Identify and evaluate process improvements and/or course correction/course alignment opportunities. Qualifications - Bachelor's Degree and 8 years of experience in IT demonstrably solid performance in a role working with cross-functional teams (within IT and/or within the business) on enterprise-level or complex/novel system implementations or equivalent work experience based on Edwards criteria. Requirements - Expertise in Angular Reactive Form development with complex dynamic fields and validations. - Broad technical knowledge and expertise in multiple aspects including hardware, software, web/mobile/desktop applications, databases, cloud platforms and services, systems engineering, and QA/testing. - Advanced experience and technical knowledge of Angular 17+, JavaScript/TypeScript, SQLite, Node JS, HTML5, CSS, Electron, Ionic Capacitor, mobile and desktop app security. - Advanced expertise in SQL database architecture and development, especially in the context of offline applications using SQLite, including distributed database systems and strongly denormalized data models. - Expertise in Continuous Integration (CI) practices utilizing Git-based Source Control, Pipelines (i.e. Bitbucket, Azure DevOps), Powershell and Node JS scripting, automated Unit and e2e testing for web applications. - Experience developing offline Windows mobile (UWP) and desktop (Win32) applications using tools such as Electron, Node JS, Microsoft Visual Studio, Native (C++) Node Modules, Win32 and Windows RunTime APIs. - Experience developing offline iOS (iPhone/iPad) applications using Hybrid Web technologies such as Apache Cordova or Ionic Capacitor. - Relevant industry experience (e.g. medical device, pharmaceuticals, etc.) or in highly regulated environments. - Excellent analytical, detail-oriented, organized and information seeking skills. - Experience and training in the specific technologies that will be used for development required. - Excellent organization and time management skills. - Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives. - Extensive knowledge and understanding of computer science fundamentals. - Extensive troubleshooting/debugging skills. - Ability to manage multiple tasks and work towards long-term goals. - Strict attention to detail. - Ability to interact professionally with all organizational levels. - Ability to manage competing priorities in a fast-paced environment. - Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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. Benefits

• Develop an annual product marketing plan and execute to effectively market Edwards products to various stakeholders, including Edwards internal teams, clinicians and hospital administrators. • Develop comprehensive marketing plans including strategies and tactics in case of major product launches • Lead the execution of product launches in collaboration with regional partners as appropriate including stakeholders readiness (e.g., training on product, messaging, and competition) • Build relationships with key opinion leaders (KOL) to help inform product communication and understand current market environment and competition • Develop product marketing campaigns and messages based on regional strategies, knowledge of current literature, current competitive environment, and regulatory/legal requirements • Develop product materials and programs that support product differentiation and commercialization strategies • Lead major projects to enhance Edwards' congress presence • Drive marketing collateral/labeling through all relevant legal and regulatory approval processes through collaboration with relevant cross-functional stakeholders • Develop the clinical story that supports the regional value proposition for Edwards' products • Manage budgets related to product line, campaigns and projects • Analyze clinical and market data to assess regional impact of activities • Other Incidental Duties

Title: Senior Specialist, Medical Writing, Remote US Locations: USA - California – Irvine USA - Washington - Seattle USA - Arizona – Phoenix USA - Colorado – Denver time type Full time job requisition id Req-44779 Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. This position is US Remote based. Posting locations are listed for job board tags only. How you will make an impact: - As a key member of the Clinical Science team, the Sr. Specialist, Clinical Science/Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across TMTT. - Perform and maintain systematic literature searches, developing search terms and criteria, extracting relevant clinical data, and writing clear and concise summaries of the data to support the development of clinical evaluation reports and clinical study reports - Develop routine, sustaining medical writing documents/deliverables; propose approaches to developing moderately complex documents/deliverables - Review and provide thoughtful feedback on moderately complex cross-functional deliverables (e.g., clinical study data, risk management documents, IFUs, SSED) using clinical and technical knowledge - Serve as the primary contact, negotiating deliverables, timelines, and resolving project-related issues with assistance, in collaboration with cross-functional stakeholders - Assist in the implementation of continuous process improvements as it relates to medical writing - Other incidental duties What you’ll need (required): - Bachelor's Degree in a related field with 5 years of related experience working in medical affairs, clinical affairs and/or clinical science or equivalent work experience based on Edwards criteria Required What else we look for (preferred): - Advanced degree (Master’s, PHD, Pharm D) - Experienced with literature reviews and various publication databases including PubMed and Embase. - Experience in authoring clinical evaluation reports - Familiarity with the cardiovascular therapeutic area—including, but not limited to, structural heart interventions, coronary interventions, heart failure—and current treatment landscape; familiarity with clinical research and/or clinical trial experience. - Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations. - Familiarity with FDA PMA applications. - Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulations. - Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel. - Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously - Excellent oral and written communication skills - Experience with maintaining current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge - Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat - Strong analytical, problem-solving, and scientific writing skills - Strict attention to detail - Ability to interact professionally with all organizational levels - Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects - Ability to build productive internal/external working relationships - The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first. 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 $106,000 to $149,000 (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. #LI-Remote 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.

Role Description Enjoy the flexibility of working remotely—this position is 100% remote within the U.S. Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. - Evaluate global complaint information provided, conduct additional investigation as needed and escalate as appropriate. - Evaluate complaints for Medical Device Reporting (MDR). - Prepare and submit MDR reports to FDA. - Process complaint files from initiation to closure. - Fulfill FDA, ISO and other relevant requirements for designated complaint handling unit, and evaluation of events for reportability to applicable regulatory bodies. How you will make an impact: - Assess complaint information provided and conduct additional investigation as needed and escalate as appropriate. - Seek information and input, and challenge as appropriate, from Product Safety, Engineering and other departments/business units for complaint investigations. - Evaluate complaints for Medical Device Reporting (MDR). - Prepare and submit MDR reports to FDA. - Identify problems and lead projects to improve processes, procedures, and/or practices; recommend and resolve solutions, including devising new approaches to problems encountered. - Summarize findings, including a review of the investigation, product analysis, imaging review, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions. - Evaluate event to determine if it qualifies as a complaint. - Manage customer relationship and expectations during course of complaint investigation and resolution process. - Prepare and submit final customer correspondence. - Lead and plan agenda for and run weekly meetings to discuss complaint issues with affected functions (e.g., Manufacturing, Quality Assurance, Suppliers, etc.) to identify assignable root cause, resolve open action items, and gather additional technical information to resolve complaint. - Analyze and/or audit complaint data/files and may develop reports. - Lead the investigation of complaints that include all complex scenarios. - Other duties assigned by Leadership (Attend cross-functional meetings to represent Quality Compliance and present open items for which resolution is needed). Qualifications - Bachelor's degree plus five (5) years of experience with complaint handling and evaluating complaints for MDR (Medical Device Reporting); or equivalent work experience based on Edwards criteria. - Medical Device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment/industry experience. Requirements - Experience submitting Medical Device Reports. - Proficient knowledge of medical terms and human anatomy. - Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing. - Strong knowledge and familiarity with 21 CFR 820 & 803 regulations. - Proven expertise in MS Office Suite and ability to operate general office machinery. - Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills. - Demonstrated problem-solving, critical thinking, and investigative skills working relationships. - Substantial knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance. - Ability to manage confidential information with discretion. Benefits - Competitive salaries. - Performance-based incentives. - A wide variety of benefits programs to address the diverse individual needs of our employees and their families. Company Description 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.

• Lead country-level strategic planning, AOP, and forecasting processes in alignment with regional governance • Own leadership meeting cadence, agendas, and execution follow-through • Consolidate forecast, sales, and market inputs from regional sales leaders to ensure consistency and transparency • Prepare high-quality, executive-ready materials for business reviews and leadership forums • Drive a high-performance, accountable, and customer-focused culture • Own commercial KPIs, dashboards, and standardized performance reporting • Translate data into insights, trends, and clear recommendations to support leadership decision-making • Identify performance gaps and lead continuous improvement initiatives • Partner closely with sales leadership to drive execution excellence, including segmentation and account planning • Establish and scale best practices and operational standards across the organization • Manage pricing governance in partnership with regional pricing teams

• Educate and train physicians, hospital personnel and hospital staff on all aspects of technical matters related to investigational products and procedures including imaging through conducting and/or coordinating one-on-one ad hoc training sessions and in-service structured education programs on two or more therapies or one highly specialized therapy, while translating training needs, providing consultation on complex situations and proposing dynamic solutions • Act as a expert in providing education on all aspects on two or more therapies or one highly specialized therapy of assigned device(s), device handling, implantation and troubleshooting techniques related to equipment, tools and products required for device implants including full certification for independent case support while influencing decisions and facilitating new relationships to prepare new sites while influencing decisions and monitoring compliance in new sites • Lead continuously improvement of training curriculum, training materials and training tools, based on clinical trial experience, EW guidelines and SOP • Provide coaching, mentoring, and knowledge transfer to team member on launch and complex activities • Responsible for certification of the centers, physicians and other related staff, as well as EW personnel and as outlined within EW SOP • Identify potential adoption strategies • Lead clinical support activities, changes in the market and assigned accounts, as well as, competitive activity with cross-functional teams (e.g., sales)

• Виконувати аналіз кореневих причин та усунути несправності бізнес-систем, інтерфейсів, конфігурацій тощо. • Оцінити бізнес-потреби призначеної функціональної області. • Налаштування та тестування Salesforce.com та інших систем. • Розробка функціональних специфікацій для системних функцій та звітів. • Документування технічного дизайну, який буде використовуватись для впровадження.