Senior Manager, Clinical Patient Screening

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 Innovation & Technology (AI&T) 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 AI&T 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’ll make an impact:

• Serve as the functional lead for imaging-based patient screening, ensuring high quality patient selection aligned with protocol, procedural feasibility, and clinical objectives.
• Lead imaging and procedure development activities supporting preclinical and clinical programs, ensuring imaging and procedural strategies are clinically executable and aligned with device intent.
• Execute and oversee screening workflows in collaboration with site managers, principal investigators, internal imaging/CT screeners/echocardiography.
• Provide subject matter expertise during bench, cadaveric, and clinical activities to guide imaging use, procedural flow, and technical decision making
• Develop screening and imaging related plans, metrics, and updates, and communicate risks, trends, and recommendations to project teams and leadership
• Partner with R&D and imaging technology vendors to influence device design, imaging workflows, and procedure optimization across the product lifecycle.
• Monitor screening performance metrics, adjudicate complex eligibility questions, and drive continuous improvement in screening efficiency and enrollment quality
• Collaborate closely with Clinical Affairs, Regulatory Affairs, Quality, R&D, and other stakeholders to support clinical execution, regulatory readiness, and program milestones.
   

What you'll need (Required):

• Bachelor's Degree in Engineer or Scientific related (Biology, Lifesciences), with 8 years previous related experience working in Medical Device/Structural Heart Disease or Healthcare Industry Required
• This position will be in office sitting on site at our Irvine, California Campus. Relocation is available from within USA.

What else we look for (Preferred):

• Master's Degree or equivalent 6 years related experience working in Medical Device/Structural Heart Disease or Healthcare Industry Preferred
• Ph.D. or equivalent in or Equivalent Engineering or Scientific field, 4 years years experience Preferred
• Other: Certifications within ARRT CT, ARDMS Adult Echo, ACS, Registered Professional Nurse, Nurse Practitioner, or Physician’s Assistant Certifications Preferred
• Solid working knowledge of Good Clinical Practice (GCP) and clinical research requirements as they apply to imaging review, patient screening decisions, and documentation
• Clear and effective communicator, able to explain imaging based decisions and recommendations to clinical, technical, and cross functional stakeholders
• Ability to independently interpret complex imaging datasets and translate findings into clear patient eligibility recommendations
• Experience executing imaging based patient screening workflows, including collaboration with site teams, investigators, and internal screening resources
• Strong analytical skills applied to identifying trends, variability, and improvement opportunities in imaging and screening data
• Hands on experience with advanced cardiovascular imaging, with strong emphasis on cardiac CT for patient screening, anatomical assessment, and procedural planning
• Proficiency using advanced imaging and analysis software, such as 3mensio, TomTec, Vitrea, Circle CVI, or equivalent platforms
• High attention to detail with consistent focus on data quality, documentation accuracy, and audit readiness
• Experience providing hands on imaging and procedural guidance during bench, cadaveric, or early clinical studies
• Prior involvement in protocol development, CRF inputs, or clinical documentation related to imaging and pa