Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you’ll make an impact:

Provide mentoring and guidance to team members on clinical development expertise.Provide cross functional technical leadership on multiple clinical development projects including providing advice and guidance to multiple key stakeholders on creating new ideas for how to develop technical summaries, clinical risk assessments, design of validation protocols and reports, design and application FMEAs (Failure Modes and Effects Analysis), for technical and clinical documentation in KOD product development.Provide advice on clinical development requirements and complex and/or multiple project management timelines and resources to cross-functional team on the successful completion of product lifecycle management for all projects including those with significant complexityDevelop project plans and activities to R&D teams on larger scale and complex projects to establish the project deliverables, and manage changes to the project scope and scheduleDesign, review and/or conduct literature searches and complete literature reviews for multiple complex design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports to identify new needs for cross functional projectsProvide mentoring, coaching, and training to team members on clinical competence and provide cross-functional teams on clinical development roles, education and awarenessCreate and/or review necessary regulatory documents for OUS studies (e.g., CIB, Clinical Investigator Brochure Create clinical strategies for cross-functional product team to execute first in man use for new products and lead the execution of timelines of protocol development for clinical feasibility proceduresProvide technical leadership and guidance to team members for cross functional responsibilities

What you'll need (Required):

Bachelor's Degree in in biological, Lifesciences, or Engineering, with 10 years experience of previous related experience in Class II and III medical device technologies and/or clinical studies background Required

What else we look for (Preferred):

BSN, P.A, or M.D Experience with documentation management systems (e.g., Ignite)Proven successful project management skills Proven expertise in MS Office Suite, Adobe, and ability to operate general office machineryExcellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skillsDemonstrated problem-solving and critical thinking skillsRecognized as an expert in own area with specialized depth within the organizationExpert knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studiesExpert understanding of pre-clinical testing protocols, hospital environments and sterile techniquesExpert knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g. iMedidata)Excellent written and verbal communications skillAdvanced problem-solving skillsAbility to manage confidential information with discretionStrict attention to detailAbility to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organizationAbility to manage competing priorities in a fast-paced environmentRepresents leadership on projects within a specific area interfacing with project managers and teamProvides guidance to others on area of expertiseAdhere 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.