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Requisition ID: 6208180315
Johnson & Johnson's Family of Companies is recruiting for a Principal Engineer aligned to Biosense Webster (BWI), located in Irwindale, CA.
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
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 Principal Engineer adds value through the knowledge of process engineering; provides support to the stabilization and to the life cycle of projects for continuous improvement from the identification to the execution and closing in terms of cost, quality, efficiency and time cycle. Quick response to operations in: technical resolutions, change of direction, manufacturing scalability, process development/operations product and material replacement. Can complete projects in his/her work area or with suppliers, in order to provide an interrupted flow of components for the assembly operations, that has the established requirements of instruments, quality, cost and delivery times.
DUTIES & RESPONSIBILITIES
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate
- Must know and follow the policies and procedures of the company in which he/she works at, related to work activities of his area of responsibility, as well as ensuring that his/her subordinates know and follow the policies of the company and the procedures related to their work activities and area of responsibility.
- Completes the trainings in the area of responsibility within the assigned period of time. The training is required for the changes and implementations of existing policies and procedures, new functions, etc. Completes the retraining in areas such as safety and environment.
- Follows all the safety policies of the company and safety precautions within the work area. Promotes safety to all the associates that enter the work area.
- Responsible for the leadership and execution of projects focused on the reduction of the variation originated by process and/or product design that influences positively in the metrics of the business, strategic directions and financial results.
- Maintains updated work plans for projects through the year such as design changes in the products that are base of the business (extension in product lines), process changes and cost improvement projects.
- Identifies and executes cost improvement projects to support the manufacturing supply chain goals and/or of the suppliers.
- Directs technical projects in his/her manufacturing site and/or with suppliers, in order to improve the capacity process, maintenance, instruments assembly capacity and the performance of the produced instruments.
- Provides technical support for the approval and validation of the changes and improvements in the processes within his/her manufacturing site and/or with the supplier.
- Provides technical support for the resolution of Quality problems of the components.
- Potentially coordinates supervision activities in MEST technical areas (Manufacturing Engineering Science and Technology) (RMI/CAD/BOM).
- Maintains the continuity of the supply chain qualifying and validating the tools through the approval procedures of the components.
- Ensures the closing of non-conformities of the component problems, besides their timely correction and the approval of control plans within his area or of the suppliers.
- Responsible for communicating business related issues or opportunities to next management level
- 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 ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed.
- Plans, directs and conducts projects of great reach and meaning for the Company, with complete technical responsibility due to the interpretation, organization and coordination of all the tasks.
- Contribute with inventions, designs or techniques, that are significant to the solution of important problems.
- Mentor other professionals in the development of behaviors aligned with the leadership standards.
- A minimum of Bachelors of Science Degree (preferably in Engineering) and a minimum of eight (8) years of related experience and/or training is required. Masters or Doctorate in Science or Engineering is preferred.
- A minimum of eight (8) years of experience in a product development/manufacturing environment or equivalent experience is required.
- Experience in the medical product industry is preferred.
- Ability to work multifunctionally and obtain collaboration among multiple functional groups is required.
- Ability to manage projects, lead teams in different places performing projects is required.
- Knowledge of GMP/ISO is highly preferred.
- Efficiency in word processing programs, spreadsheets, presentations and data base applications is preferred.
- Knowledge of Statistical analysis software is preferred.
- Engineering applications software (FEA, CAD, etc.) is preferred.
- Travel up to 30 % both domestically and internationally is required.
- Experience in one or more of the following technical competences is preferred:
- Tool design
- Product/process risk assessment
- Cleaning validation
- Equipment design and automatization
- Interplant transfers
- Test methods development and validation
- Lean and Six Sigma skills
- Process validation
- Design validation and verification
- Operations direction
- Process technical writing
- Regulations knowledge
- Plastic injection molding
- Plastic processing
- Mechanical and electrical skills
- Process characterization
- Geometric Dimensions and Tolerances (GD&T)
- FEA (Finite Element Analysis)
- Knowledge of polymers
- Chemical processing
- Electrical, electronic and PLC
- DFMA (Manufacturing and Assembly Design)
- Development of the assembly and equipment process
- Calibrators development and metrology
- PLC (troubleshooting)
Be VITAL in your career. Be seen for the TALENT you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
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.
Biosense Webster Inc. (6010)