Johnson & Johnson Careers

Senior R&D Program Manager

Irwindale, California
Product Development


Job Description

Requisition ID: 3101180927

 

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 increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.  

 

The Senior R&D Program Manager has ultimate responsibility for the execution of the project. The position leads and manages development activities, resolves conflicts, coordinates project schedule and budget, and leads preparations and presents Stage Gate Reviews. The position assumes complete responsibility of the project to ensure, on-time, on budget, per plan delivery of quality products.

Candidate should have experience in managing programs in the medical device space with knowledge of regulatory and quality requirements. Proven experience in product development from early feasibility to commercialization and in managing complex tasks and delivering innovative solutions. Strong multidisciplinary background with comprehensive knowledge of systems engineering. Good understanding of quality systems, regulatory requirements, development and manufacturing processes.

Duties & Responsibilities

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the manager is expected to perform the following:

  • Lead cross functional project teams in a matrix environment to drive project from initiation to product launch in multiple geographies by following appropriate product development process
  • Guide project team activities to meet project and business objectives including approval of project recommendations through governance; Drive team accountability for deliverables and ensure projects meet milestones
  • Ensure projects are executed in compliance with regulatory & procedure requirements
  • Demonstrate business acumen, project management, communication, process management and team performance management; ask the right questions to understand business impact and risks
  • Represent complex problems in a simplified manner to represent a true enterprise view when presenting opportunities and plans to the organization and senior management
  • Lead team through options analysis and drive cross-functional recommendations
  • Develops budgets and comprehensive plans for product development and ensures delivery on plan and on budget
  • Evaluates market reactions to existing products to ensure the timely adjustment of development strategy and plans to meet changing market and competitive conditions
  • Recommends changes in basic structure and organization of product development group to ensure the effective fulfillment of objectives assigned to it and provide the flexibility to move swiftly in relation to market problems and opportunities
  • Performs other duties assigned as needed
  • Excel at project facilitation, collaboration, attention to detail Identify and recommend the best enterprise business proposition
  • Define scope and ensure stakeholder alignment, resource and risk management, project leadership, team development and communication
  • Lead teams in use of ongoing risk management & communication tools
  • Proactively identify and escalate risks and issues to relevant stakeholders; lead development and delivery of tactical and achievable mitigation and contingency planning
  • Interact with external customers to understand ongoing market trends and customer needs
  • Develop, manage and maintain up-to-date MS Project Timelines inclusive of all critical milestones, key interdependencies and resource constraints, while applying appropriate project scheduling techniques
  • Monitor project status and execution; report timely updates via Project Templates, Project Dashboards and Update Forms; and develop agendas, minutes, metrics, etc. for the teams.
  • Deliver transparent, timely and effective verbal and written communication to teams, stakeholders and appropriate levels of the organization
  • 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
 


Qualifications
Qualifications
  • A minimum of a Bachelor's of Science in Mechanical Engineering or Electrical Engineering or Biomedical Engineering or equivalent is required
  • A minimum of ten (10) years of experience demonstrating increasing responsibility is required
  • A minimum of five (5) years in managing teams including demonstrated leadership of cross functional teams across geographies is required
  • A proven record of Project management including in-depth knowledge of project management processes and methodologies is required
  • Experience in leading Medical Device projects including knowledge of class II and class III devices is preferred
  • Knowledge in electrophysiology space is preferred
  • Technical leadership of electromechanical device design, system integration and integration of capital equipment and disposables is preferred
  • Strong Business and Financial acumen is required
  • Demonstrated ability to work through influence, negotiation and partnering is required
  • Demonstrated success in launching products from a matrix environment is preferred
  • This position will be based in Irwindale, CA and may require up to 30% travel both domestic and internationally
 
 


Primary Location
United States-California-Irwindale
Organization
Biosense Webster Inc. (6010)
Job Function
Product Development
Requisition ID
3101180927