Manager, New Product Introduction

Edwards Lifesciences has a new Manager, New Product Introduction opening. This hybrid role will ideally be based near our Irvine location. The NPI role is 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. This role will 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 inputs into the development of the Global Supply Chain (GSC) project resource plan including analysis around the people, expense and capital needed support project execution. Give 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.
• Update all relevant project information in tracking tools such as Clarizen.
• Travel required
• Determine and discern detailed requirements on large scale 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
• Provide direction and guidance to small project teams to execute tactical supply chain projects and/or initiatives:
• Drive make vs. buy and manufacturing siting decisions with key stakeholders. Aligns decisions with senior leadership.
• Establish, provide analysis and track progress against agreed upon key business and operating metrics related new product launches and commercialized products as assigned.
• Ensure Manufacturing Readiness Reviews occur in advance of major builds
• Lead the 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.
• Prepare and lead the facilitation of the Supply Chain Readiness Reviews aligned with project phase gates.
• Review and approval for assigned product development process (PDP) documents.

Required Qualifications:

• Experience leading cross functional teams without direct line reporting authority
• 3 years of experience in development and introduction of new products into Supply Chain
• Bachelor's Degree in Engineering or Technical field, 8 years of previous related work experience
• Experience in preparing for and presenting project status to executive leadership, including the development and managing of dashboards
• Experience working with regulatory authorities, notified bodies and other industry standards
• Master's Degree or equivalent in Engineering or Technical field, 6 years of work experience

Preferred Qualifications:

• Experience in multiple areas of Supply Chain such as Sourcing, Manufacturing, Planning and/or Distribution
• Experience within the medical device or other regulated business

Additional Skills:

• Extensive 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
• Extensive knowledge in own area with specialized depth and breadth of expertise within area of work in the organization
• Ability to negotiate with and influence key stakeholders across the organization
• Ability to be a strong collaborator and communicator with a high degree of emotional intelligence
• Ability to develop and manage project budgets, understanding of business case development including net present value and internal rate of return on capital investments.
• 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
• Proven successful project management leadership skills
• Strict attention to detail
• 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 documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Ability to understand business partner needs and manage satisfaction relative to deliverables.
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to see interdependencies within the company and comprehend how decisions affect other departments.
• Ability to set clear expectations and orchestrate all Operations activities related to Planning Sourcing, Manufacturing, Distribution and other functions
• Proven expertise in both Microsoft Office Suite, including advanced Excel and related systems
• Ability to explain complex concepts and strategies in understandable terms.
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Extensive understanding of critical to quality (CTQ) design elements and cascading CTQs to design inputs / outputs and establishing process controls / limits

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 $106,000 to $151,000 (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.