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
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
+ A Bachelor?s Degree in Science/Technology/Engineering/Mathematics or equivalent is
+ 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
Primary Location
United States-California-Diamond Bar
Biosense Webster Inc. (6010)
Job Function
R&D Engineering (R&D)
Requisition ID

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