J&J Family of Companies Senior Director, R&D and New Product Development in Irvine, California
Senior Director, R&D and New Product Development - 2306110454W
Biosense Webster part of the Johnson & Johnson family of companies is currently recruiting for a Senior Director, R&D and New Product Development . This position can be based in multiple J&J MedTech locations within the United States if the candidate can travel to the work sites of Irvine, CA and Salt Lake City, Utah 50% of the time.
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 Director, is responsible for the research and development and operations activities related to new and existing products, including the direction of all research activities. They will investigate new technologies and the design and development of company product in accordance with J&J standards and customer requirements/requests. They are responsible for budgets, timeline for product introduction, and compliance with all regulatory requirements in R&D and manufacturing phases of new products. The incumbent will provide technical as well as administrative direction to staff.
ESSENTIAL DUTIES AND RESPONSIBILITIES :
Through direct reports, ensure that all products are designed, developed, and manufactured in compliance with the company’s Quality Management System, Quality Policy, and regulatory requirements of the countries into which the products will be marketed
Work with direct reports and technical management in the development of new products and product enhancements. Provide feedback from customers and scientific advisors to the process.
Provide critical design and technical problem resolution; give technical expertise and remain involved in day-to-day activities of product development
Lead and monitor project tracking to ensure timely flow of projects from conception through manufacturing and regulatory approvals
Direct the development and preparation of short- and long-term plans, and budgets based upon the broad operating company goals and growth objectives.
Initiate process improvements and establish infrastructure for future growth
Responsible for supervision, training, and development of staff on the R&D and operations teams; monitor progress of team members to assure they meet the requirements of their positions
Effectively communicate project goals and establish staff responsibilities and project tasks/deadlines
Recruit, hire, and retain a versatile and flexible team who can meet varying project and business needs
Maintain fiscal responsibility through monitoring departmental budget and assuring money is spent in accordance with company policies and objectives
Ensure functional requirements, deliverables, timelines, and budget are met; develop and deliver reports to senior management on these topics
Ensure product development activities are documented in accordance with GMP/FDA requirements
Select vendors for capital equipment purchases which are in accordance with company guidelines
Identify and implement Cost Improvements Projects (CIPs) to increase efficiency, reduce complexity and improve the standard cost of the product
Initiate the Annual Business Plan, including all Plant Expenses, Capital Plan, Headcount, CIPs and Standard Costs
Analyze production and operating reports and resolve operational, manufacturing, and maintenance problems to ensure minimum costs and to prevent operational delays
Ensure new products or product enhancements are designed to facilitate transfer to manufacturing in a timely and cost-effective fashion
Ensure that Johnson & Johnson Credo Values are recognized and taken as a foundation for decision making in day-to-day business
Build an engaged workforce through positive employee relation practices and establish a plan for continuous staff development
Communicates business related issues and opportunities to next management level
Coordinate all activities and maintain records related to intellectual property including documentation for patent submission. Further, work directly with patent counsel to determine the most effective strategy in US and foreign filings to meet company objectives
Stay ahead of industry technical advancement to ensure that other companies are not infringing on company patents, trademarks, or copyrights
Ensure that adequate resources are provided to support Quality System activities and to follow applicable regulatory requirements
Review and monitor the goals and initiatives for overall suitability and effectiveness of the Quality System in accordance with the management process
Identify actions to improve the Quality System when appropriate
Actively promote and support the Quality Management System and Quality Policy of the company
Maintain an awareness of Quality System procedures and requirements, including regulatory requirements, involved in activities of functional team members, and assure that appropriate procedures are followed
Bachelor’s degree AND a minimum of 15 years of medical device industry experience, including 5 years of technical management responsibilities
Experience in E2E Supply Chain, cGMP, People Management, and Project Management
Previous experience working with preclinical testing, clinical trials, and data collection
Solid knowledge and interpretation of applicable regulations, guideline and policy statements (QSR, MDD, and ISO)
Experience working under quality systems designed to meet governmental regulations
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
The anticipated base pay range for this position is $182,000 - $362,365.
Primary Location NA-US-Utah-Salt Lake City
Other Locations NA-United States, NA-US-California-Irvine
Organization Coherex Medical, Inc. (6226)
Job Function R&D
Req ID: 2306110454W
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