Edwards Lifesciences

Leading and managing clinical trial monitoring activities, ensuring compliance with regulatory standards, and mentoring team members. | Bachelor's degree in a related field, extensive clinical research experience, and strong understanding of regulatory requirements and cardiovascular health. | 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. Innovation starts from the heart. Our Advanced Technology (AT) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AT team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology. How you will make an impact: Managing and leading a small team within assigned function including team budget responsibilities and managing outside contractors/vendors. Developing team members to increase business acumen and functional skills. Providing input on strategic direction on field monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., KOL site), acting as a Core Team lead, assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determining if clinical trial/study subject documentation is within parameters of study hypothesis, as well as monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. Leading in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities. Acting as a mentor to new or junior level employees. Overseeing clinical trial conduct including management of metrics (e.g., dashboard), compliance, protocol deviations, and data entry cadence. Participating and contributing to the development of clinical protocols, informed consent forms, and case report forms. Participating in development and validation of case report forms. Reviewing and approving monitoring visit reports. Resolving complex trial/study data and regulatory documentation discrepancies escalated by junior level employees. Reviewing and completing checklist on informed consent forms (ICF). Providing direction and guidance to execute project deliverables in collaboration with project managers. Identifying and evaluating clinical process improvement opportunities. What you’ll need (Required): Bachelor's Degree in related field with previous field monitoring experience, quality assurance/control and regulatory compliance required or equivalent work experience based on Edwards criteria. Ability to travel up to 75% domestically and internationally. What else we look for (Preferred): 8+ years of related experience in cardiology trials Master’s Degree in related field Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification) Strong understanding of ISO 14155, FDA, and international regulatory requirements Ability to lead and mentor field monitors Strong understanding of risk-based monitoring, strategies and tools to ensure compliance and data integrity Ability to resolve conflicts and provide clear guidance Proficiency in trial management systems (e.g. RAVE, CTMS, Veeva, & monitoring dashboard) Proven successful project management leadership skills Proven expertise in MS Office Suite, including Word, Excel, and Adobe Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives Excellent problem-solving, organizational, analytical and critical thinking skills Extensive understanding of clinical studies procedures while defining team operating standards and ensuring essential procedures are followed based on knowledge of own discipline Extensive understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise Demonstrated skill set to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization Ability to work and excel within a fast paced, dynamic, and constantly changing work environment 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 $123,000 to $174,000 (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. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

Build and maintain scientific relationships, serve as a medical SME, support scientific engagements, and generate insights from healthcare professionals. | Requires a clinical background, extensive experience in medical or clinical research, and knowledge of cardiac medical devices, which do not match your HR-focused background. | Patients are at the heart of everything we do. As part of our Medical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Senior Manager, Medical Science Liaison – Surgical Business Unit, will be a field‑based role within the Medical Affairs department. This position requires travel throughout Pennsylvania, Massachusetts, New Jersey, New York City, Washington, D.C., and Ohio. Candidates based in the Northeast or Mid‑Atlantic regions are highly preferred. How you will make an impact: Build and Maintain Scientific Partnerships: Establish and sustain scientific and clinical relationships with external key opinion leaders, healthcare professionals, and academic or strategic centers in order to foster a credible, compliant scientific exchange of ideas and enable the timely flow of external insights and emerging evidence to internal stakeholders; focused on complex, high‑impact, non‑routine engagements with mid‑to‑large hospital systems. Serve as Scientific and Medical SME: Serve as a subject matter expert for external key opinion leaders, healthcare professionals, and academic or strategic centers in the field to enhance scientific understanding and support the appropriate integration of Edwards products into clinical practice. Support Scientific Engagements and Medical Meetings: Serve as a scientific resource at congresses, advisory boards, educational meetings, and other Medical Affairs initiatives, including supporting content development, insight capture, and program execution. Support Research and Investigator Sponsored Studies: Respond to unsolicited inquiries related to Investigator‑Sponsored Studies (ISS) and facilitate submissions through appropriate internal review and governance processes. Provide Medical Information and Support Scientific Exchange: Act as the primary point of contact for unsolicited medical inquiries, delivering accurate, balanced information on product use, safety, and off‑label data in accordance with available scientific evidence and company standards. Generate Insights: Capture, analyze, and share insights from HCP interactions and scientific engagements to inform Medical Affairs and internal stakeholders Expected field-based travel of 50-60% to meet with physicians at hospitals with some weekend responsibilities to attend conferences. What you will need (Required): Bachelor's Degree 10 years of work experience Master's Degree or equivalent 8 years of related experience working in clinical trials What else we look for (Preferred): Clinical background strongly preferred (MD, PA, RN) Experience in the structural heart space (TAVR, transcatheter valve therapies, or surgical valve therapies) Background in cardiac medical devices Medical Device Industry experience Proven successful organizational and project management skills Recognized as an expert in own area with specialized depth within the organization Expert understanding of related aspects of Medical Affairs concepts and principles 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. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

Support and optimize sales enablement initiatives, analyze business metrics, and collaborate cross-functionally to improve sales strategies and patient access. | Requires 8+ years in sales operations, business strategy, or related healthcare experience, with strong analytical, communication, and technical skills. | Make a meaningful difference to patients around the world. Driven by a passion to help patients live healthier and more productive lives, our Sales teams embrace Edwards Lifesciences’ values to build trusting, lasting relationships with medical professionals and industry partners. Your insight and dedication will help deepen and broaden clinical knowledge of our company’s innovative technologies, while creating connections between providers and teams across our businesses to ensure patients receive the highest quality of care. This is an exciting opportunity for an experienced Sales Enablement professional to join a team that is boldly designing transcatheter mitral and tricuspid therapies from the ground up. TMTT is dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives. As part of the Transcatheter Mitral and Tricuspid Therapies Sales Enablement team, this role supports our growing national field sales team, as well as the broader TMTT organization. Serving as the area operations business manager, you will partner closely with the Area Vice President of Sales to drive commercial success. You will leverage key business metrics, pricing, sales, and market trends (and much more) to partner with our sales organization and cross-functionally in improving patient access to lifesaving technologies. We need your strategic mindset, exceptional talents, and creativity to scale the insights and solutions we deliver to the broader business. How you will make an impact: Serve as the operations business manager for the Central region • Partner closely with Area Sales leadership as a trusted liaison, contributing to business reviews, strategic planning, operational efficiency and other key initiatives • Apply deep expertise in Area business trends, pricing, rebates and contracts to deliver actionable analyses and insights through comprehensive workups and rigorous account due diligence • Generate strategic insights for management decisions via ad hoc analyses, reporting and scenario modeling • Consolidate and transform complex data and analyses into compelling presentations that communicate results, recommendations, and insights to management • Own Sales Enablement platforms, leading systems onboarding, technical troubleshooting and cross-functional partnership to ensure seamless operations Lead strategic sales enablement initiatives that deliver measurable business outcomes through cross-functional collaboration with key partners such as Marketing, Sales Operations, Sales Training, Physician Training, and IT. Examples include: • Deploy and optimize customer segmentation models, ensuring alignment of business resources to high-value opportunities • Drive utilization and effectiveness of cross-functional customer-facing programs by improving visibility, assessing impact and refining strategies in partnership with key stakeholders • Design, deliver and train on customer-facing and internal sales tools that enhance decision-making and accelerate business growth What you'll need (required): • Bachelor's Degree in related field of study, 8+ years of previous related sales operations, business strategy and/or financial planning experience or equivalent work experience based on Edwards criteria • Willingness to work Area local hours • Travel a minimum of 30% What else we look for (preferred): • Master’s Degree or equivalent with 6+ years of related experience working in Sales, Marketing or Sales Operations in the medical device, healthcare or cardiovascular space • Excellent written, verbal and visual communication skills; Ability to communicate technical concepts clearly and concisely in written and presentation form, and to present information and respond to questions from all levels of the organization. • Strong business acumen and organizational skills • Experience in a customer-facing role with demonstrated ability to engage with clients • Ability to work independently without close supervision. • Ability to manage project timelines and demonstrated accountability to commitments. • Must be able to work in a team environment. • Excellent analytical ability, including advanced technical proficiency with tools such as Excel • Experience using data visualization tools to develop dashboards such as Tableau or PowerBI • Capability to adapt to proprietary systems such as Salesforce.com (SFDC) The time is now to join TMTT and shape mitral and tricuspid therapies that will transform treatment. Don’t miss your chance to be part of a dynamic, challenging, and rewarding environment that offers potential for growth and professional advancement for the right candidate. 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. 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. 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 Illinois (IL), the base pay range for this position is $121,000 to $171,000 (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.

Manage project activities, oversee cross-functional teams, and implement CAPA programs to ensure quality standards in medical device development. | Bachelor's in related field, experience in quality engineering or regulatory compliance within medical devices, and management of engineering disciplines. | • This role is required to be onsite. Selected candidate must reside within a reasonable commuting distance to Edwards campus in Draper, Utah. We are also willing to provide relocation assistance for candidates willing to move to the Salt Lake City metro area. Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Sr. Manager, Quality Engineering position is a unique career opportunity that could be your next step towards an exciting future. 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. How You'll Make an Impact: • Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope and objectives while using engineering methods (e.g., SIX Sigma and LEAN methods), employing technical design skills to re-design/design on new products and/or processes. Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups • Manage and/or oversee the work of assigned team within own function and/or cross functional project teams and may have some budgetary responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department • Provide technical guidance to cross-functional and/or departmental groups to develop and provide design recommendations that integrate into component(s) or product(s) with moderate complexity • Lead the implementation of CAPA program including training, approvals, and system effectiveness • Other incidental duties What You'll Need (Required): • Bachelor's Degree in related field, related experience in engineering or equivalent work experience based on Edwards criteria Required and • Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry or equivalent work experience based on Edwards criteria Required and • Demonstrated track record in management of technical and/or engineering disciplines or equivalent work experience based on Edwards criteria Required What Else We Look For (Preferred): • Experience working in a regulated industry or equivalent work experience based on Edwards criteria Preferred • Proven successful project management leadership skills • Proven expertise in both Microsoft Office Suite and related systems • Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making • Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives • Expert understanding of engineering procedures while addressing issues with impact beyond own team based on knowledge of related disciplines • Expert understanding of related aspects of quality engineering processes and/or systems • Expert knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, and ISO/EN standards) • Expert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods and Lean Manufacturing • Knowledge of financial acumen as it relates to the business as well as quality engineering • Demonstrated ability to direct teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations • Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality engineering to the business • Serve as core partner to senior leaders in Business Units, Functional Groups, Regions and IT • 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 work and excel within a fast paced, dynamic, and constantly changing work environment • Frequently interacts with subordinate production supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company; often leads a cooperative effort among members of a project team • Participate and present at meetings with internal and external representatives • Resolve operational and scheduling issues • Dedicated to quality client service and pro-active and responsive to client needs. • Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness. • Develop relationships and leverage them to influence change • Support and solicit input from team members at all levels within the organization • 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 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.

Develop and execute upstream product marketing strategies for medical devices, engaging with R&D, clinical, and marketing teams to shape product development and launch. | Requires extensive experience in healthcare or medical device marketing, clinical knowledge, project management skills, and a proven track record in product launches. | Group Product Manager, Upstream Marketing-TMTT Innovation starts from the heart. Heart valve disease and critical care therapies impact millions of lives, spanning all ages and geographies. As communities globally address the opportunities and challenges of cardiovascular care, telling a compelling and authentic story is more crucial than ever. Beyond raising awareness, our Marketing teams build lasting, trusted relationships with medical professionals and industry stakeholders to ensure patients can receive the treatments they need. 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 we prepare for the next phase of growth for EVOQUE, we are seeking an experienced upstream marketing leader who brings deep strategic marketing capability, cross‑functional influence, and the ability to drive clarity and progress in ambiguity. This is a high‑ownership role designed for a proactive, seasoned marketer who can immediately lead key NPD, strategy, and VOC workstreams. Position Summary: Develop and execute the upstream product marketing strategy for the EVOQUE TTVR portfolio. Engage cross‑functional partners including R&D, Clinical, Global Marketing, and regional commercial teams to define market needs, shape product strategy, and influence new product development. Your contributions in this role will directly impact the evolution of TR therapy and Edwards’ leadership in this emerging space. This is an on-site role based in Irvine, CA How you will make an impact: Develop and lead in the execution of comprehensive marketing plans including strategies and tactics for multiple major product launches or programs and initiatives Build relationships with key opinion leaders (KOL) to help inform product launch plans and understand current market environment and competition Conduct in‑depth competitive landscape and clinical evidence assessments to guide strategy. Translate insights into clear value propositions, claims, and product positioning. Influence R&D priorities through strong understanding of market dynamics, workflows, and customer pain points. Act as a connector across R&D, Clinical, Regulatory, Quality, HEOR, Medical Affairs, and Global Marketing. Identify issues and risks early; bring forward solutions and drive alignment through collaborative leadership. Lead early commercialization planning, including messaging frameworks and evidence strategy inputs. Develop product materials and programs that support product launch and commercialization strategies for multiple major product launches or programs and initiatives Drive labeling through all relevant legal and regulatory approval processes through collaboration with relevant cross-functional stakeholders for multiple major product launches or programs and initiatives Develop IFU required for regional product approvals for major product launches or programs and initiatives Define and build a body of clinical and economic evidence that supports the regional value proposition Manage budgets related to product line, campaigns and projects Lead significant process or corporate initiatives that impact and bring value to the marketing organization Other Incidental Duties What you will need (required): Bachelor's Degree or Equivalent in related field, minimum 10 years experience of previous related experience working in marketing or healthcare industry or equivalent work experience based on Edwards criteria Required OR Master's Degree or equivalent in related field, 8 years experience of previous related experience working in marketing or healthcare industry or equivalent work experience based on Edwards criteria Preferred Other: Certification in related discipline Required What else we look for (preferred): Experience in upstream marketing Proven successful project management skills Proven expertise in Microsoft Office Suite Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives Recognized as an expert in own area with specialized depth within the organization Expert understanding of related aspects of marketing concepts and principles Extensive understanding of broad market research designs, develops market research programs coordinating with the global VOC manager and demonstrates an in-depth understanding of commercial goals behind research Ability to forecast product lines for short-term and long-term accuracy based on market development, sales trends, competition and changing market dynamics. Ability to assess and understand market share, pricing, ASPs, competitive dynamics Possess strong clinical knowledge, experience and knowledge of the clinical areas where Edwards' products are used or intended to be used, understand the purchasing process and challenges for product adoption in complex healthcare networks 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 Represents leadership on projects within a specific working closely with cross-functional team, marketing peers and leaders and managing needs and messaging to upper management Consult in project setting within specific marketing area 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 (CA), the base pay range for this position is $145,000 to $205,000 (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. Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

Lead end-to-end user experience design for digital health products, including research, wireframing, and usability testing, within a clinical context. | Extensive experience in UX/UI design for digital health or medtech products, strong prototyping skills, and understanding of clinical workflows and medical device standards. | 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, Product Design UX/UI) 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. We’re seeking a Director, Innovation (Digital Early Incubation, Product Design UX/UI) who blends strong UX research capabilities with hands-on UX/UI design. This strategic role will own end-to-end discovery and delivery – from framing the clinical problem, conducting research, and synthesizing insights to designing UX/UI and validating solutions to drive a new and evolving digital innovation portfolio for the future of the organization. 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, define strategies for demonstrating clinical proof-of-concept for software prototypes, and understand market adoption criteria 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 Oversee the end-to-end user experience for digital products in the AI&T incubator, building a strong design culture within the organization Lead generative UX research studies to complement voice-of-customer (VOC) market research in collaboration with the product manager Lead UX design for developing and implementing intuitive high-fidelity user interface (UI) prototypes and iterations, to be ultimately used in the clinic/hospital setting Collaborate with product manager (PM), technical program manager (TPM), and software engineers (SWE) on requirements, roadmaps, and execution of project deliverables Understand and define clinical workflow and user (clinician and/or patient) interaction with the digital product, rapidly creating wireframes to outline the experience Optimize user workflows for scalability and adaptability Lead and execute rapid user/usability testing, synthesizing feedback into actionable design improvements for digital prototypes 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 Industrial Design or Computer Science strongly preferred) Strong track record of UX/UI design for new early-stage software/digital product development initiatives in the medtech domain, working in a cross-functional team environment Experience in design strategy and design thinking Experience designing for digital products/services spanning multiple hardware platforms (e.g. desktop, tablet, phone) Strong interaction and visual design skills, experience using common prototyping tools (e.g. Figma, Adobe XD, Sketch, etc.) Experience in structuring, conducting, and synthesizing UX research (qualitative and quantitative methods) 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 Experience with MedTech/healthcare workflows, EHR integration, clinical environments, or FDA/IEC usability standards strongly preferred Basic understanding of front-end development (HTML/CSS) for effective collaboration Strong and inspirational presentation skills, adaptable to various audiences ranging from design reviews to executive-level forums Experience with data visualization Experience with product use cases involving medical imaging (e.g. CT, MRI, echo/ultrasound) or image processing Practical knowledge of clinical and biostatistics 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 Understanding of business strategy, competitive landscape, regulatory environment, and clinical data Familiar with regulatory, compliance, and related requirements for medical device development (or SaMD) Demonstrated ability to develop relationships to drive alignment of objectives Proven successful organizational and project management skills 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. Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide. For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

Design, implement, and technically own the enterprise LIMS system, manage platform roadmap, ensure compliance and security, and lead global IT transformation efforts. | Bachelor's degree, 10+ years IT experience, professional architecture certification, hands-on LIMS experience, regulatory knowledge, server and database skills, and strong communication in a global matrix environment. | 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. The IT Senior Application Architect, LIMS, will serve as the technical owner of our enterprise Laboratory Information Management System (LIMS) reporting to the Director, IT Business Partner of Global Quality and Lab Technologies. As the IT Senior Application Architect, LIMS, you will be a key member of a global quality technical transformation team implementing and guiding the technical evolution and optimization of LIMS across a global organization. How you’ll make an impact: • Design and implement LIMS technical solutions to meet business requirements. • Oversee all technical delivery for LIMS and assume technical ownership of the system. • Define and implement IT LIMS standards, ensuring alignment with global IT and industry best practices for software development and system implementation. • Manage the technical platform roadmap, including regular platform updates and prompt resolution of IT security vulnerabilities within established SLAs. • Advocate for remediation of technical debt and continuous system improvements to drive business growth and development. • Partner with business leaders to understand organizational needs and assess implementation complexity for both in-house and project-funded initiatives. • Act as a steward for LIMS integrity, making informed recommendations to minimize unnecessary customization and preserve system purpose. • Execute a shift-left strategy for support and maintenance, transferring Level 2 (L2) support to the global team while retaining Level 3 (L3) support, problem management, and change management within the transformation team. What you'll need (Required): • Bachelor's Degree in Computer Science, Information Systems, Natural Sciences & Mathematics or a related discipline • A minimum of ten years experience in IT • A professional certification (e.g. TOGAF, COBIT, ITIL, OCP, CDMP, etc.) in related disciplines and architecture frameworks What else we look for (Preferred): • Hands-on experience designing, configuring, implementing, and maintaining enterprise LIMS with a preference toward direct experience with LabWare and LabVantage • Experience working with 21 CFR part 11. • Experience working with in a regulated environment, and strong understanding of GxP concepts and regulatory compliance in a pharmaceutical/medical device setting. • Experience with commercial off the shelf applications and a solid understanding of the importance master data structure plays in a scalable enterprise solution. • Experience writing and executing validation deliverables (e.g., IQ/OQ/SDD) in the software development life cycle (SDLC) for validated, regulated, applications. • Strong background in server-client and/or web hosted application architecture, integrations to applications and equipment; preference for experience with laboratory instruments and enterprise systems (such as ERP and MES). • Experience with server administration required to support an enterprise application. • Experience with structured query language (SQL) and relational databases. • Experience / knowledge with remote desktop and other web hosting platforms. • Experience working with application vendors, and 3rd party consulting companies on technology implementations and delivery. • Comfortable communicating and presenting ideas/recommendations to a senior leadership level. • Experience working in a global, highly matrix, and team-oriented IT environment. • High energy, self-motivation, and results-driven mindset with an excitement to learn new technologies. • Have a passion for our mission at Edwards Lifesciences. If you are passionate about advancing laboratory information management, thrive in collaborative global teams, and want to make a significant impact on business and IT transformation, we invite you to apply. 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 $136,000 to $192,000 (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.