Hybrid Senior Manager, New Product Introduction

at Edwards Lifesciences

• Job title: Senior Manager, New Product Introduction
• Job type: Full Time
• Experience level: Senior
• Salary: $139,000 - $196,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Irvine, United States

About the role

• Senior Manager leading Global Supply Chain activities for new product launches. Responsible for delivering innovative devices and technologies to enhance patient lives.

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

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
• Advanced degree or MBA (preferred)
• 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.

Benefits

• Competitive salaries
• Performance-based incentives
• Wide variety of benefits programs to address the diverse individual needs of employees and their families