Johnson & Johnson Careers
Manager Lifecycle Engineering and Labeling
Requisition ID: 0372180822
Manages labeling project portfolio and product lifecycle management design/manufacturing projects in support of business objectives and strategies, regulatory and compliance requirement changes and supply chain strategies. Manages resources to execute Quality, Delivery, Cost improvement projects that maintain global continuity of quality supply for CSS Electrophysiology products.
Manages and works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and technologies for obtaining solutions.
Improves existing processes and leverages best practices across CSS. Determines direction and adequacy of processes/technologies/designs and test results and recommends changes. Directs, coordinates, and exercises project management principles, methods, tools and techniques for the effective planning scheduling, organization, control, integration, and completion of project(s) of limited scope and duration by performing the following duties personally or through subordinates. Individual will have demonstrated creativity, foresight and mature technical judgment in anticipating and solving problems, determining technical program objectives/requirements, organizing/leading projects and developing standards & guides for technical activities.
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
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Develops strategies, project plans and execution of projects for the product management and labeling functions in partnership with the business units.
- Leads the labeling change process for the creation, revision and approval of labeling and packaging artwork components such as Instructions for Use (IFUs), manuals, cartons, product labels, E-labeling and other applicable labeling components.
- Has robust understanding of general systems and proposes improvements to support business needs.
- Has strong problem solving skills to support and guide staff with respect to lifecycle management projects being executed, while ensuring subject matter/technical expertise is available as needed.
- Maintains product label design and process knowledge for those platforms responsible.
- Maintains labeling procedures and compliance to standards.
- Oversees execution of labeling changes in alignment with input, scope and content defined by a cross functional team from Regulatory, Clinical, Quality, R&D and others as needed.
- Escalates and manages supply events while partnering with the Quality organization to ensure robust CAPAs and NCRs, while ensuring issues are challenged adequately using critical thinking and problem-solving techniques.
- Anticipates potential risks, developing corresponding contingency plans, and managing important unplanned events or disruptions. Accountable for integrating and coordinating impact analysis, response development, communications planning, and execution associated with these unplanned events that impact continuity of quality supply.
- Provides leadership to develop a robust pipeline of engineers and labeling subject matter experts.
- Ensures proper collaboration with finance to ensure that project finances are properly understood, accurate, and maintained throughout the project.
- Influences in a highly matrixed environment
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for ensuring that 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, if applicable
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
- Minimum of a Bachelor of Science degree in engineering, science or information systems is required
- 8+ years of relevant work experience is required;
- Experience in the Medical Device industry or medical field is preferred
- Knowledge of Regulations and Standards for labeling is preferred
- Supply Chain, Information Systems or Operations experience is preferred
- Ability to work cooperatively across functions is required
- Ability to perform duties in accordance with policies and procedures is required
- Verbal and written communication skills are required
- Presentation skills are required
- Problem Solving skills are required
- Talent management and development is preferred
- Information systems experience is preferred
- Leadership experience with projects and processes is preferred
- Project management experience is preferred
- Change management experience is preferred
15% expected domestic and international travel, as required
Do you strive to join an outstanding team that is dynamic and
ever-changing? Is career growth and opportunity appealing to you? Apply to this
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)