Edwards Lifesciences Project Manager – Transcatheter Mitral and Tricuspid Therapies in Irvine, California
Project Manager – Transcatheter Mitral and Tricuspid Therapies
This is an exciting opportunity for an exceptional project management professional with a moderate amount experience 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.
The Project Management Office (PMO) in the TMTT group at Edwards has the responsibility to support all the New Product Development, Operations, Regulatory, Clinical Affairs, Medical Affairs projects/programs, and support Marketing with domestic and international commercial expansion. As the Sr. Analyst for the PASCAL transcatheter repair program, you will support new product launches of the important PASCAL project, in support of the TMTT strategy.
Determine the detailed requirements for new product launches of the PASCAL program, develop the project management plan, and manage changes to the project scope, schedule, quality requirements and costs to keep the project management plan updated and reflective of authorized project changes.
Lead and coordinate multiple parallel workstreams across all departments and functions involved in preparation for introduction of new products to the market, managing dependencies, monitoring and assessing project risks, all to ensure the company achieves operational readiness at the planned product launch date.
Establish and manage effective working relationships with other project managers assigned to numerous simultaneous departmental projects to ensure operational readiness for the new product market launch
Lead the execution of tasks as defined in the project management plan and actively manage project risk.
Assess project performance to monitor the progress of the PASCAL program, identify and quantify variances, perform required corrective actions and communicate to all stakeholders.
Establish and coordinate team members and stakeholder relationships, expectations, and communications.
Manage design and phase gate reviews, design history files and project documentation.
Manage project closure activities, including gathering lessons learned.
Support additional new product development programs within TMTT as-needed.
A bachelor's degree in a related field is required; a technical degree is a plus. Must have a minimum of five years’ experience in direct project management for a new product development or new product launch team; implant and delivery systems experience strongly preferred;
Experience managing projects in medical device industry is required; Class III medical device experience is a plus.
Experience managing new product launches is strongly preferred
Ability to work in a fast-paced environment, stay organized and multi-task.
Outstanding candidates will be well-versed in project management; project management certification is a strong plus.
Extraordinary documentation and communication skills are required; influencing others at all levels of the organization is essential.
Experience managing risk and implementing mitigation plans.
Strong MS Project, Excel, Word, and PowerPoint skills required.
Strong sense of diplomacy and ability to influence others at all levels of the organization
Proven ability to excel in a team environment
Edwards experience preferred
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.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 13,000 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.