Senior Manager, New Product Introduction

Edwards Lifesciences•Irvine, CA

1d•$139,000 - $196,000

About The Position

This role can be based in Irvine, CA or Draper, UT. Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives. The Senior Manager is a functional leader who will be responsible for leading Global Supply Chain (GSC) activities from concept development through commercialization, required for the readiness and successful launch of new Delivery System Network products to the market. The Senior 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. How you’ll make an impact: Development and execution of a Supply Chain Plan for Delivery System Network 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. 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. 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. Develop the 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.

Requirements

Bachelor’s degree in engineering or scientific.
Minimum of 10 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.
Up to 15% travel.

Nice To Haves

Advanced degree or MBA.
Certification in related discipline (e.g., CPIM Certification or Project Management Certified, Green Belt Certified).
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.
Expert knowledge of design controls for Class II & III medical devices, including familiarity with one or more of the following: device sterilization, 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.
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.
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.
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.

Responsibilities

Development and execution of a Supply Chain Plan for Delivery System Network 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.
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.
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.
Develop the 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.