New Product Introduction Operation Manager Jobs

Imagine how your ideas andexpertisecan change a patient's life. Our GlobalOperations &Qualityteam plays a central part in ensuring our products are delivered to patients with cardiovascular disease.You'llpartner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

Aortic stenosis impacts millions of people globally, yet it oftenremainsunder-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence.It'sour driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

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. This is a functional leader who serves 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:

• Lead the development and execution of a comprehensive Supply Chain Plan for new product programs based on Global Supply Chain (GSC) short- and longer-term strategies and initiatives, while ensuring that the objectives of the new product development program are being met. Ensure plan integration into the NPD/I process through early collaboration with BU partners, which may include the program R&D heavy weight team lead, NPD, program management, regulatory, and marketing.

• Establish a business continuity roadmap for new products, ensuring supply disruption and quality risks are readily identified throughout the product development. Develop mitigation strategies, plan, and execute to enable a seamless launch in partnership with the BU and supply chain partners.

• Maintain communication plan with the BU and supply chain stakeholders by preparing and leading Supply Chain Readiness Reviews in alignment with program phase gates, ensuring Manufacturing Readiness Reviews occur in advance of major builds, and leading any other relevant supply chain or transfer meetings.

• Establish business and operations KPI targets based on analyses, input, and alignment from Pilot, commercial manufacturing, and other SC functions as needed. Develop and maintain plans to meet these program and commercial targets.

• Develop the Global Supply Chain (GSC) project resource and funding plan including people, expense, and capital expenditures to support project execution. Provide these key inputs to manufacturing network and BU strat planning, AOP, and forecast cycles as needed.

• 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.

• 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.

• Lead the transfer of new products into External Manufacturers, Pilot and Commercial Manufacturing facilities by working closely with business partners from those areas. Employ the use of PM methodologies to manage and track all activities, including use of Clarizen and Microsoft Project. Continue to drive product launches into additional markets. Drive visibility to risks and mitigations with BU and SC stakeholders and senior leadership.

• 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.

• Review and approval of assigned product development process (PDP) documents.

• Perform other duties and responsibilities as assigned.

What you'll need (Required):

• Bachelor's Degree in engineering or scientific discipline.

• Minimum of 12 years of manufacturing operations experience, including 5 years leading the development, transfer, and/or introduction of new products into supply chain in a regulated environment.

• Proven experience leading cross functional teams without direct line reporting authority.

• Travel up to 15% domestically and internationally.

• Onsite requirement.

What else we look for (Preferred):

• Advanced degree or MBA preferred.

• Certification in related discipline preferred (e.g., APICS CSCP Certification or Project Management Certified, Green Belt Certified).

• Experience within the medical device industry.

• 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.

• 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.

• 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.

• 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.

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 $159,000 to $226,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.