Edwards Lifesciences Corporation

Lead and manage clinical trial programs for pediatric pulmonary valve disorders, ensuring regulatory compliance and successful project delivery. | Requires extensive experience in clinical trial management, regulatory knowledge, and preferably experience in the medical device industry. | 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. How you will make an impact: • Lead a clinical trial program focused on treatments for pediatric pulmonary valve disorders. • Manage clinical trials activities and ensure all applicable regulatory requirements are met. Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables for larger or more complex clinical trials in accordance to GCP, all applicable regulations, and SOPs. Serve as the primary lead of assigned clinical trial(s) • Provide direction, guidance, and oversight of clinical core teams to execute larger or more complex projects and initiatives. Determine clinical trial resources and set priorities for projects • Manage project status and appropriate communication both internally and externally. May present trial information at executive and/or industry conferences • Analyze trial performance to plan and develop corrective actions. Identify and communicate study risks, recommend and lead in the implementation of mitigation strategies in alignment with management • Provide mentoring and coaching to other project team members • Oversee the selection of clinical vendors and study sites What you'll need (required): • Bachelor's Degree in related field, 10 years experience of previous related experience 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 or equivalent work experience based on Edwards criteria Preferred • Travel up to 30% nationwide What else we look for (preferred): • Structural heart experience, specifically pulmonary valve disorders • Clinical trial experience • Experience working in a large manufacturing company or equivalent work experience based on Edwards criteria Preferred • Certification in related discipline Preferred • Proven successful project management skills • Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred • Excellent written and verbal 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 knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols • Expert understanding of regulatory submissions, reporting, and audits • Ability to manage confidential information with discretion • 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 area interfacing with project managers and clinical team • Consult in project setting within specific area • Provides leadership to outsourcing partners on a task level, and may participate on small scale RFP • 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. The base pay range for this position is $139,000 - $196,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., geographic location, 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.

Lead and manage complex clinical trials for pediatric pulmonary valve disorders, ensuring regulatory compliance and project success. | Requires extensive clinical trial experience, industry-specific knowledge, and leadership skills, which are not demonstrated in your health research background. | 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. How you will make an impact: • Lead a clinical trial program focused on treatments for pediatric pulmonary valve disorders. • Manage clinical trials activities and ensure all applicable regulatory requirements are met. Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables for larger or more complex clinical trials in accordance to GCP, all applicable regulations, and SOPs. Serve as the primary lead of assigned clinical trial(s) • Provide direction, guidance, and oversight of clinical core teams to execute larger or more complex projects and initiatives. Determine clinical trial resources and set priorities for projects • Manage project status and appropriate communication both internally and externally. May present trial information at executive and/or industry conferences • Analyze trial performance to plan and develop corrective actions. Identify and communicate study risks, recommend and lead in the implementation of mitigation strategies in alignment with management • Provide mentoring and coaching to other project team members • Oversee the selection of clinical vendors and study sites What you'll need (required): • Bachelor's Degree in related field, 10 years experience of previous related experience 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 or equivalent work experience based on Edwards criteria Preferred • Travel up to 30% nationwide What else we look for (preferred): • Structural heart experience, specifically pulmonary valve disorders • Clinical trial experience • Experience working in a large manufacturing company or equivalent work experience based on Edwards criteria Preferred • Certification in related discipline Preferred • Proven successful project management skills • Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred • Excellent written and verbal 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 knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols • Expert understanding of regulatory submissions, reporting, and audits • Ability to manage confidential information with discretion • 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 area interfacing with project managers and clinical team • Consult in project setting within specific area • Provides leadership to outsourcing partners on a task level, and may participate on small scale RFP • 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. The base pay range for this position is $139,000 - $196,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., geographic location, 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.

Support sales operations and strategic initiatives to improve business outcomes and patient access. | Requires 8+ years in sales operations, business strategy, or related healthcare experience, with strong analytical and communication 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 Presidentof 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 West 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. For California (CA), 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.

Support sales operations and enablement initiatives to improve business outcomes and patient access. | 8+ years in sales operations, business strategy, or related experience, with proficiency in data visualization tools and CRM systems. | 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 Presidentof 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 East 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. 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.

Design, implement, and own the enterprise LIMS technical solutions, manage platform roadmap, ensure compliance and system integrity, and lead technical delivery and support within a global regulated environment. | Bachelor's degree in related field, 10+ years IT experience, professional certification in architecture frameworks, hands-on LIMS experience preferred, knowledge of regulatory compliance, server administration, SQL, and strong communication skills. | 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.