Senior Engineer, New Product Development.

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Job description

Biosense Webster, a member of Johnson & Johnson family of companies is recruiting for a Senior Engineer, New Product Development 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 increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.

Duties and Responsibilities

• Identifies, designs and develops the crucial equipment related to new product development.
• Responsible for preparing and managing specifications. Performs material tests.
• Assists technicians and engineers on unusual problems. Purchases and designs equipment that meets safety and environment requirements.
• Responsible for developing new manufacturing and assembly processes consistent with Design for Manufacturability for new product introductions! Performs activities of process/product validation.
• Continuously seeks automation opportunities of new and existing processes to reduce costs and improve quality on new products.
• Provides on-demand production line support, managing manufacturing metrics (yields, cycle times, capacity, bottlenecks), ensuring adherence to quality and compliance procedures, identifying and implementing continuous process improvements, deploying new fixture and tooling, performing line audits, supporting manufacturing documentation updates, and training manufacturing personnel!
• Leads and coordinates the work of engineers and technicians in controlled environment. Responsible for communicating business related issues or opportunities to next management level
• Responsible for presenting business-related issues or opportunities to next management level
• Responsible for ensuring personnel and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Lead or support troubleshooting activities, validations, and raw material/process improvements. Perform root cause analysis of failures. Work on special projects as requested by management.
• Up to 10% travel, domestic and international
  
  

Qualifications

• A bachelor's degree is required in Engineering or related. Master's in Science is preferred.
• A minimum of 5 years of related experience in a regulated work environment is required.
• Experience in in the medical device industry is preferred.
• Experience with technical report writing, statistical analysis and data evaluation is required.
• Knowledge of good manufacturing practices and documentation in the medical industry
• Strong Project Management experience and skills are preferred.
• The ability to influence others to achieve business objectives, and excellent written and oral communication skills is required.
• Knowledge of production processes, standard costs and work standards highly preferred
• Ensure personal and company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Proficiency to understand and speak Spanish is a plus
  
  

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

Engineering

Requisition ID

W

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