Edwards Lifesciences Manager, Program Management - New Product Development in Irvine, California
This Manger, Program Management - New Product Development (NPD) is an exciting opportunity to be a part of the growing Transcatheter Heart Valve organization. This project management position is focused on medical device new product development projects. You will have a key role in owning the Product Development Process tools and templates; drive continuous process improvement and refinements across teams and company.
The Manager, Program Management - NPD initiates, plans, executes, controls and manages all aspects of project(s) to ensure ultimate project success.
Manages large-scale New Product Development projects and/or programs for the development of devices used in transcatheter heart valve replacement procedures.
Collaborates with all project functions including R&D, Quality, Manufacturing, Marketing, Clinical, Regulatory and Supply Chain.
Responsible for leading the project team through the phases and gates of the Edwards design control process.
Responsible for all areas of project management, focusing heavily on schedule management, performance metrics, resource management, risk management, communications management, and process development and improvement.
Develops a high-level milestone plan for the program and manages program change in accordance with the change management plan to control scope, quality, schedule and cost
Executes program plans (quality, risk, communication, staffing, etc.) and communicate program status and data in order to maintain accurate and current program information for the use of stakeholders
Responsible for coordinating with, presenting to, and establishing rapport with all levels of project stakeholders including mid-level and executive functional and business unit leadership, global supply chain, shared services, and corporate counterparts.
May serve as a representative of the Project Management Office (PMO) in working directly with PMOs in other Edwards business units and enterprise-wide initiatives.
Serves as a project and program management subject matter expert, including guiding and mentoring project managers; sourcing and directing contract resources tied to projects within the program; and develops expertise in a business process, professional discipline, market or product.
Establishes and maintains program stakeholder relationships, expectations, and communications, both internal and external to the organization.
Owns one or more PMO continuous improvement activities.
Bachelor's Degree in a related field
10+ years of hands-on experience managing projects and/or programs of increasing complexity
Experience within a regulated environment
Strong leadership skills and ability to influence change
Experience in facilitating change, including collaboration with management and executive stakeholders
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
Strict attention to detail
Proven expertise in usage of MS Office Suite and related project management systems
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Expert understanding and knowledge of principles, theories, and concepts relevant to managing multiple projects within an overall program
Excellent problem-solving, organizational, analytical and critical thinking skills
Excellent understanding and work experience with project budgets and financial management
Must be able to work in a team environment, including external representatives and participating and presenting at meetings
Ability to provide guidance to others on area of expertise
Ability to lead meetings
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 15,000 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.