Director, New Product Introduction

The Director, New Product Introduction 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. Serve as a core team member on new product development teams ensuring alignment across functions and all regional and global supply chain stakeholders.
Key Responsibilities:

• Provide direction and guidance to project teams to execute tactical supply chain projects and/or initiatives:
• Update all relevant project information in tracking tools such as Clarizen.
• 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.
• Prepare and lead the facilitation of the Supply Chain Readiness Reviews aligned with project phase gates.
• Review and approval of assigned product development process (PDP) documents.
• 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.
• 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.
• 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.
• Perform other duties and responsibilities as assigned.
• Provide leadership and guidance to cross functional team members for successful attainment of project milestones. Support the development of a robust talent pipeline in alignment with functional growth strategies of the department including coaching, mentoring, and knowledge transfer.
• 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.

Education and Experience:

• 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.
• Experience in preparing for and presenting project status to executive leadership, including the development, and managing of dashboards.
• Experience in multiples areas of Supply Chain such as Sourcing, Manufacturing, Planning and/or Distribution preferred.
• 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 in a regulated industry.
• Understanding of critical to quality (CTQ) design elements and cascading CTQs to design inputs / outputs and establishing process controls / limits.
• Bachelor's Degree in engineering or scientific discipline
• 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.
• Ability to set clear expectations and orchestrate all Operations activities related to Planning Sourcing, Manufacturing, Distribution, and other functions.
• Experience leading cross functional teams without direct line reporting authority.
• Strong project management skills and ability to explain complex concepts and strategies in understandable terms.
• 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.

Preferred Qualifications

• Experience within the medical device industry.
• Advanced degree or MBA preferred.
• Certification in related discipline preferred (e.g., CPIM Certification or Project Management Certified, Green Belt Certified).

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).
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.