Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner 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 often remains under-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’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
The Senior Manager, New Product Introduction will be responsible for leading Global Supply Chain activities from concept development through commercialization, required for the readiness and successful launch of new products to the market. They 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 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.
- 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.
- 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.
- 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.
- Establish, provide analysis and track progress against agreed upon key business and operating metrics related new product launches and commercialized products as assigned.
- 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.
- Drive make vs. buy and manufacturing siting decisions with key stakeholders. Aligns decisions with senior leadership. Ensure adequate business continuity plans are developed to guarantee the highest level of services to customers.
- 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.
- Review and approval for assigned product development process (PDP) documents.
What you'll need (Required):
- Bachelor's Degree in an Engineering or Technical field with previous related work experience
- At least 5 years of experience in development and introduction of new products into Supply Chain
- Experience working with regulatory authorities, notified bodies and other industry standards
- Experience leading cross functional teams without direct line reporting authority
- Experience in preparing for and presenting project status to executive leadership, including the development and managing of dashboards
What else we look for (Preferred):
- Master's degree
- Experience working in the medical device industry
- Experience in multiple areas of Supply Chain such as sourcing, manufacturing, planning, and/or distribution
- Proven successful project management leadership skills, Project Management certification
- Proven expertise in Microsoft Office Suite and related tools and systems
- 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
- Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
- Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
- Expert 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
- Expert understanding of critical to quality (CTQ) design elements and cascading CTQs to design inputs / outputs and establishing process controls / limits
- Knowledge of financial mechanism that relates to Global Supply Chain (NPD/I)
- Strict attention to detail
- 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.
- Ability to be a strong collaborator and communicator with a high degree of emotional intelligence
- Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
- Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
- Ability to see interdependencies within the company and comprehend how decisions affect other departments.
- Ability to explain complex concepts and strategies in understandable terms.
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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 $139,000 to $196,000 (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.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.