Edwards Lifesciences Manager, Engineering New Product Introduction- TMTT in Irvine, California
This is an exciting opportunity to lead new product introduction activities for Class III devices for Edwards Lifesciences comprehensive portfolio of Transcatheter Mitral and Tricuspid Therapies. The Manager will be responsible for leading Global Supply Chain (GSC) activities from concept development through commercialization, required for the readiness and successful launch of new products to the market. The Manager will serve as a core team member on new product development teams ensuring alignment across functions and all regional and global supply chain stakeholders.
Essential job functions:
Development and execution of a Supply Chain Plan for assigned New Product Development / Introduction (NPD/I) projects. Ensure appropriate 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.
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.
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.
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.
Establish, provide analysis and track progress against agreed upon key business and operating metrics related new product launches and commercialized products as assigned.
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.
Review and approval for assigned product development process (PDP) documents.
Bachelor’s degree in engineering or scientific with a minimum of 10 years of combination experience in NPI/NPD and manufacturing engineering.
5 years of experience in development and introduction of new products into supply chain.
Experience working with regulatory authorities, notified bodies and other industry standards.
Experience leading cross functional teams without direct line reporting authority.
Experience in preparing for and presenting project status to executive leadership, including the development and managing of dashboards.
Experience within the medical device or other regulated business.
Experience in multiple areas of Supply Chain such as Sourcing, Manufacturing, Planning and/or Distribution.
Proven successful project management leadership skills
Proven expertise in both Microsoft Office Suite, including advanced Excel and related systems.
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.
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
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.
Ability to develop and manage project budgets, understanding of business case development including net present value and internal rate of return on capital investments.
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.