Edwards Lifesciences Engineering Manager, New Product Introduction – Critical Care Disposables in Irvine, California
The Engineering Manager who will be responsible for leading Critical Care Operations activities from concept development through commercialization, for the readiness and successful launch of new products to the market through the Global Supply Chain (GSC). The Engineering Manager will serve as a core team member on new product development teams, ensuring alignment across functions and all regional and global supply chain stakeholders.
Essential job functions:
Development and execution of an Operations Integration Plan for assigned 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, Regulatory 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 and operations integration strategy.
Lead a team of Operations Integrators to support the development, transfers, and commercial launches of new advanced hemodynamic monitoring products from the Critical Care Disposables portfolio.
Manage large scale to enterprise-wide product launch projects, including partnering with cross functional teams (e.g., Planning, Sourcing, Distribution, Logistics, R&D Engineering, and Manufacturing), on the integration of New Products into manufacturing, with an outlook towards product lifecycle management and other operational responsibilities.
Prepare and lead the facilitation of the Manufacturing Readiness Reviews aligned with project phase gates and major builds.
Establish, analyze, and track progress against agreed upon key business and operating metrics related to new product launches and previously commercialized products as assigned.
Develop the GSC project resource plan including people, expenses, 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 plans to meet gross profit targets.
Drive make vs. buy and manufacturing site decisions with key stakeholders. Align decisions with senior leadership. Ensure adequate business continuity plans are developed to guarantee the highest level of service to customers.
Ensure successful transfer of new products into External Manufacturers and Commercial Manufacturing facilities by working closely with respective business partners. Continue to drive product launches into additional markets. Ensure risks and mitigations are known to stakeholders and senior leadership.
Perform other duties and responsibilities as assigned.
Bachelor's Degree in Engineering, preferably in Biomedical, Mechanical or Electrical.
Minimum 10 years of experience in the medical device (or highly regulated) industry.
Proven successful project management leadership skills.
Strong collaborator and communicator with a high degree of emotional intelligence.
Master's Degree in Engineering.
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.
Expert knowledge of design controls for Class II & III medical devices, including familiarity with one or more of the following: device sterilization, electromechanical devices, plastics, disposables devices, hemodynamic devices, and catheters.
Expert understanding of critical to quality (CTQ) design elements and cascading CTQs to design inputs / outputs and establishing process controls / limits.
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 interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.
Works and excels within a fast paced, dynamic, and constantly changing work environment.
Ability to negotiate with and influence key stakeholders across the organization.
Ability to explain complex concepts and strategies in understandable terms.
Excellent documentation, communication, and interpersonal skills, including negotiating and relationship management, with ability to drive achievement of objectives.
Proven expertise in both Microsoft Office Suite, including advanced Excel and related systems.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.