Senior Manager, New Product Introduction
Edwards Lifesciences
full-time
Posted on:
Location Type: Hybrid
Location: Irvine • California • Utah • United States
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Salary
💰 $139,000 - $196,000 per year
Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
manufacturing operationsnew product developmentsupply chain managementproject managementbudget managementdesign for manufacturabilitySix SigmaLEANcGMPprocess validation
Soft Skills
collaborationcommunicationemotional intelligenceteam leadershipcoachingmentoringrisk managementstakeholder managementexpectation settingstrategic thinking
Certifications
CPIM CertificationProject Management CertifiedGreen Belt Certified