Director, New Product Introduction - Structural Surgical Heart Request ID: Req-23438 Location: [...]

Company: Edwards Lifesciences
Location: Irvine
Posted on: March 15, 2023

Job Description:

The Director of New Product Introduction will be 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.Essential job functions:

• 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.
• 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.
• Perform other duties and responsibilities as assigned.Qualifications:
  • Bachelor's Degree in engineering or scientific discipline.
  • Minimum of 12 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. Experience leading cross functional teams without direct line reporting authority.
    • 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.
    • 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.
    • Experience in multiples areas of Supply Chain such as Sourcing, Manufacturing, Planning and/or Distribution.
    • 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.
    • Understanding of critical to quality (CTQ) design elements and cascading CTQs to design inputs / outputs and establishing process controls / limits.
    • 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.
    • Ability to set clear expectations and orchestrate all Operations activities related to Planning Sourcing, Manufacturing, Distribution and other functions.
    • 15% travel.Preferred Qualifications:
      • Advanced degree or MBA preferred.
      • Certification in related discipline preferred (e.g., CPIM Certification or Project Management Certified, Green Belt Certified).
      • Experience within the medical device industry.
      • 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.Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.For California, the base pay range for this position is $141,000 to $200,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Keywords: Edwards Lifesciences, Irvine , Director, New Product Introduction - Structural Surgical Heart Request ID: Req-23438 Location: [...], Executive , Irvine, California