Senior Engineering Manager, R&D

Biosense Webster Inc. part of the Johnson & Johnson family of companies is currently recruiting for a Senior Engineering Manager, R&D located in Irvine, CA Atrial fibrillation (AFIB) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. 20 million people around the world suffer from AFIB each year. Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders. The company established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the company’s CARTO® 3 System in 2009 revolutionized 3D mapping technology by improving the accuracy, speed, and efficiency of the cardiac ablation procedure. The Sr Manager R&D has ultimate responsibility for the execution of the project and will lead projects, mentor engineers, communicate within & across teams, and share your sophisticated knowledge of mechanical engineering within the Research & Development design group to drive projects to completion. Your work will be focused on providing leadership in a fast-paced environment to a team that is enthusiastic about delivering quantitative results and creating a product that exceeds expectations of the customer DUTIES & RESPONSIBILITIES: Lead, mentor and grow a high performing talented engineering team responsible for design and development of catheter technologies for treatment of atrial fibrillation Direct the development of new concepts from initial design to market release. Help the team to clearly define complex project objectives and ensure realization of these project objectives within time and budget Partner with internal and external experts to maintain and strengthen relevant clinical and technical expertise and to contribute to strategic planning for the R&D organization Use engineering acumen, experience and customer input to drive decisions Lead collaboration with systems engineering team to ensure correct spec setting, characterization and design of disposable devices Manage high-level engineers, and other managers, involved in an array of product development and technology exploration projects Actively mentor, coach, and ensure career development plans are in place for direct reports Collaborate with core teams to establish objectives and evaluate progress of direct reports Responsible for managing functional cost center budget and resource allocation Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products Guides the conceptualization of new methodologies, materials, machines, processes or products Manages feasibility studies of the design to determine if capable of functioning as intended Monitors documentation maintenance throughout all phases of research and development Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery Selects, develops and evaluates personnel to ensure the efficient operation of the function Interact with external customers to understand ongoing market trends and customer needs Lead "lessons learned" exercises, share lessons among project leaders and other teams, integrate lessons into existing processes, tools and templates Ensures that products shipped meet specifications and quality goals. Works closely with Quality Assurance/Quality Control to ensure that the development of products meets and/or exceeds both company and Federal quality standards Performs other duties assigned as needed Qualifications A Bachelor of Science in Mechanical, Electrical or related Engineering discipline is required A minimum of 10 years of experience demonstrating increasing responsibility is required. At least 3 years of demonstrated Technical Management is required Experience in medical device industry is required Proven track record of delivering medical devices to market is highly preferred Knowledge in electrophysiology space is highly desirable Knowledge of catheter development is highly desirable Knowledge of integration of capital equipment and disposables is preferred Demonstrated knowledge of manufacturing principles, practices, and procedures is preferred Experience in design, development and commercialization of Class I-II medical devices, specifically electro-mechanical, disposable, minimally invasive, handheld surgical devices is preferred Designing with 3D CAD tools (e.g., SolidWorks, rapid prototyping) is required Command of various engineering tools such as FEA, Computational Fluid Dynamics, MATLAB, is highly preferred. Proven track record of developing engineering solutions for complex problems Experience and working knowledge of FDA regulations/ISO standards for medical devices Ability to travel up to 25%, domestic and international, is required Do you want to be part of a diverse team delivering innovative products to market? Apply today! At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-California-Irvine-31 Technology Dr Organization Biosense Webster Inc. (6010) Job Function R&D Requisition ID 2206023164W