Edwards Lifesciences Manager, New Product Introduction in Irvine, California
Responsible for leading Global Supply Chain activities from concept development through commercialization, required for the readiness and successful launch of new products to the market. Serve as a core team member on new product development teams ensuring alignment across functions and all regional and global supply chain stakeholders.
Development and execution of a Supply Chain Plan for assigned new product development / introduction (NPD/I) projects. Ensure appropriate Global Supply Chain (GSC) integration into the NPD/I process through early collaboration with NPD Team Leader, R&D and Marketing. Build relationships with business partners to ensure the alignment of Supply Chain Plan objectives and activities. Provide technical expertise and lead the facilitation of portions of the supply chain strategy.
Provide direction and guidance to project teams to execute tactical supply chain projects and/or initiatives:
Prepare and lead the facilitation of the Supply Chain Readiness Reviews aligned with project phase gates.
Ensure Manufacturing Readiness Reviews occur in advance of major builds
Update all relevant project information in tracking tools such as Clarizen.
Establish, provide analysis and track progress against agreed upon key business and operating metrics related new product launches and commercialized products as assigned.
Manage large scale to enterprise-wide product launch projects including partnering with cross-functional teams (e.g., Planning, Sourcing, Distribution, Logistics, Engineering, Pilot and Commercial Manufacturing), on the integration of New Products into manufacturing with a future look towards lifecycle management, sustaining activities and other Operations responsibilities.
Develop the Global Supply Chain (GSC) project resource plan including people, expense and capital expenditures to support project execution. Provide Operations input into the financial business case for a new product with shared responsibility for new product cost of goods sold and plan to meet gross profit targets.
Drive make vs. buy and manufacturing siting decisions with key stakeholders. Aligns decisions with senior leadership. Ensure adequate business continuity plans are developed to guarantee the highest level of services to customers.
Ensure successful transfer of new products into External Manufacturers, Pilot and Commercial Manufacturing facilities by working closely with business partners from those areas. Continue to drive product launches into additional markets. Make sure risks and mitigations are known to stakeholders and senior leadership.
Manage and oversee the work of a team with responsibilities for multiple NPD/I projects including ownership of project milestones, risks and mitigations. Develop a robust talent development plan in alignment with functional growth strategies of the department including coaching, mentoring, and knowledge transfer.
Review and approval for assigned product development process (PDP) documents.
Minimum of ten years of manufacturing operations experience with five of those years in the development and/or introduction of new products into supply chain a regulated industry.
Minimum of five years of leading cross functional teams
Bachelor's Degree in engineering or technical field
Advanced degree or MBA preferred
Experience within the medical device or other regulated business preferred
Five years in development and introduction of new products into Supply Chain required
Experience in multiples areas of Supply Chain such as Sourcing, Manufacturing, Planning and/or Distribution preferred.
Expert knowledge of design controls for Class II & III medical devices, including familiarity with one or more of the following: device sterilization, implantable NiTi, CoCr & tissue, electro-mechanical devices and catheter-based delivery systems.
Expert understanding of critical to quality (CTQ) design elements and cascading CTQs to design inputs / outputs and establishing process controls / limits.
Recognized as an expert in own area with specialized depth and breadth of expertise within area of work in the organization
Experience working with regulatory authorities, notified bodies and other industry standards
Experience leading cross functional teams without direct line reporting authority.
Ability to set clear expectations and orchestrate all Operations activities related to Planning Sourcing, Manufacturing, Distribution and other functions.
Strong business and financial acumen. Ability to develop and manage project budgets, understanding of business case development including net present value and internal rate of return on capital investments.
Strong collaborator and communicator with a high degree of emotional intelligence and the ability to understand business partner needs and manage satisfaction relative to deliverables.
Ability to negotiate with and influence key stakeholders across the organization
Ability to see interdependencies within the company and comprehend how decisions affect other departments.
Technical understanding of manufacturing engineering, design for manufacturability, design and process excellence methodologies including Six Sigma, LEAN experience, cGMP, EH&S guidelines, supplier development and process validation.
Advanced project management skills and ability to explain complex concepts and strategies in understandable terms.
Experience in preparing for and presenting project status to executive leadership, including the development and managing of dashboards.
Effective at dealing with and overcoming conflict
Certification in related discipline preferred (e.g., CPIM Certification or Project Management Certified, Green Belt Certified)
Adhere to all EHS rules and requirements 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.
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.