Edwards Lifesciences Senior Manager, Balloons R&D/NPD in Irvine, California
Edwards Lifeciences’ – Transcatheter Heart Valve team is looking for a Senior Manager to lead the Balloons R&D/New Product Development (NPD) team to develop next-generation balloon technology in support of our balloon expandable transcatheter heart valve replacement platforms. This position will support product development efforts in our aortic, pulmonic, and mitral valve replacement indications as well as develop new balloon technology to address the anticipated needs of future applications. This team is responsible for the full development cycle of the balloon component from product concept through commercialization.
Partner with the product R&D/NPD teams to translate product requirements to the balloon component level.
Provide direction and guidance for the design and characterization of new balloon concepts.
Develop and support engineers to improve the teams’ innovation, effectiveness, productivity, and communication.
Promote knowledge sharing within the team and across teams/functions; actively acknowledge good work.
Represent the balloon technology team to other internal technical partners as well as to business unit senior leadership.
Develop, communicate, and execute the strategy for the technical team to solve complex technical issues.
Manage transfer of new balloon components and processes to the commercial manufacturing sites .
Partner with commercial manufacturing sites to develop new process technology.
Qualifications and Skills:
Bachelor’s degree in Polymer Science or other relevant engineering/technical degree with a minimum of 10 years’ experience.
A minimum of 5 years of experience in polymer product development, balloon blow molding experience strongly preferred.
A minimum of 3 years of experience in a technical management role.
Proven successful project leadership skills.
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making.
Ability to foresee and manage risks within current projects and/or technology.
Experience developing strategy for and executing process validations (IQ/OQ/PQ).
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
Ability to influence cross-functional partners, business units, and/or sites.
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
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.