Johnson & Johnson Careers
DIRECTOR R&D, PROGRAM MANAGEMENT
Requisition ID: 8179180525
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 Helios Program Director is directly responsible for managing all phases of product development for all products developed under the Helios platform from conception to full market release. He will be also responsible for overlooking all activities including preclinical work for 2nd generation development with Advanced R&D ensuring transitioning it to Helios R&D program. This individual reports directly to the Helios platform lead, Biosense Webster CA, and interacts with other cross functions to ensure final product market release within the identified timelines and per specified company and Federal quality standards.
The Program Director will provide leadership to R&D development team (s) for the global development and execution of the critical device development program. The job is responsible for detailed planning & execution of the platform development while understanding and participating in strategy development and implementation with the leadership team.
The Program Director develops and actively contributes to decision-making by ensuring relevant research, analysis, and expertise and leads R&D Team to successfully develop the device such that its value is maximized over its lifecycle while costs and time are minimized without sacrificing quality. The incumbent is accountable to deliver on and report on all program metrics that are in place for the full cycle of the program, escalates and resolves issues to ensure on time, quality execution of the program, and manages program budget and resource requirements. The Program Director works with Engineering, Marketing, Manufacturing to identify, engineer and manufacture products that meet customer needs and fit identified markets. The Program Director proactively escalate critical issues to the Helios Program Lead when appropriate.
Under (e.g. limited supervision, general direction, etc.) and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• Establishes product goals to ensure share of market and profitability of products and/or serv
• Works with Engineering, Marketing, Manufacturing to identify, engineer and manufacture products that meet customer needs and fit identified markets
• Develops and executes product development plans and programs, both short and long range, to ensure the profit growth and expansion of company products and/or services
• 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
• Ensures that necessary drawings, specifications, testing are properly documented throughout product development cycle
• Manages the efforts of a team of product development engineers. Ensures project milestones are met. Meets with engineers to determine needs and support. Provides technical advice when necessary
• Interfaces with identified physicians to gather new product information. May provide and set-up product evaluations
• Plans, conducts and supervises development projects for company. Determines project needs and assigns personnel.
• Ensures development projects meet overall completion dates and technical specifications
• Works closely with Marketing to determine market needs. Identifies new products
Works with Pre-clinical and Clinical Centers of Excellence to ensure a robust eveidence generation plan
• Ensures effective control of development results and that corrective action takes place to be certain that the achievement of new product development objectives are within designated budgets
• 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
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures
• Responsible for ensuring subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
• Responsible for communicating business related
- A Bachelor’s Degree in Science/Technology/Engineering/Mathematics or equivalent is required.
- A minimum of 10 years of experience in medical device development along with at least (5) years of providing leadership on cross-functional teams preferred
- Must be familiar with development processes, documentation writing, design control, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA) and software version control preferred
- Knowledge and experience with RF systems a plus
- Program planning and financial review required
- Up to 75% travel (International as well as domestic) Weekend travel/work may be required
United States-California-Diamond Bar
Biosense Webster Inc. (6010)
R&D Engineering (R&D)