Technical Transfer & Validation Director

Johnson & Johnson Innovative Medicine•Cincinnati, OH

3d•Onsite

About The Position

This role is accountable for providing leadership to support the Biosense Product Lifecycle Engineering process. This position ensures the development and execution of quality work enabling effective and compliant medical device production/sustaining. In collaboration with Manufacturing, Quality, R&D, Commercial and Supply Chain organizations, this role ensures the success of Biosense network strategies and reliable supply of high-quality product. This leader works collaboratively with Johnson & Johnson leaders to implement Engineering programs and new technologies to improve Supply Reliability, overall quality and regulatory compliance, operational efficiency, advance innovation, enhance organizational capabilities and diversity. In this role, the Director of Engineering will lead a team of engineers across Biosense Webster in Cardiovascular & Specialty (CSS) Franchises focused on developing processes, components, and technology solutions through internal and external manufacturing operating models. Key areas of focus will include developing talent to drive key projects, driving rigorous and robust engineering discipline, partner with key stakeholders; quality, R&D, manufacturing engineering to align on technologies and strategies collaborate with Technical Operations across BWI to drive standard business processes, actively engage with the Manufacturing Operations staff.

Requirements

A minimum of a bachelor’s degree is required in an Engineering.
12+ years overall business experience.
Talent Development experience is a must.
Ability to develop people, manage technology, embrace financial goals, and utilize customer focused decision making
Change management, project management, the ability to work effectively and drive alignment in a global environment through strong communication and empowerment
Must demonstrate working knowledge of process development and validation, including design of experiments, statistical analysis, and project management
Demonstrated knowledge and expertise in bridging technical and business disciplines, evaluating, and determining appropriate risks.
Deep knowledge of continuous improvement tools, lean manufacturing, and six-sigma.
Quality and Compliance mindset with experience in medical device manufacturing preferred.
Experience in the Medical Device industry or medical field
Demonstrated knowledge of manufacturing principles and practices, and procedures
Knowledge of specific business practices and software and software applications
Experience using medical device equipment
Able to enter data on spread sheet and database applications
Ability to communicate effectively with a diverse clientele base
Experience maintaining ledgers and other fiscal documents
Ability to work cooperatively with coworkers and the public
Ability to perform duties in accordance with policies and procedures and in to comply civil rights requirements
Excellent Communication Skills, both in Spanish and English language.
Influencing – lead multi-functional teams and people to achieve consensus and optimized results.
Analytical – solves problems and achieve objectives
Problem-solving – finds innovative ways to apply engineering principles and drives efficiencies.
Experience managing projects and demonstrating project leadership abilities.
Proficiency in leading consistent with the Johnson & Johnson Leadership Imperatives.
Able to adapt to End-to-End Supply Chain solutions/applications in a fast-paced changing business environment.

Nice To Haves

Engineering degree in Electrical or Mechanical is preferred.
An advanced degree, such as an MS or an MBA is preferred.
Six-sigma black belt certification a plus.

Responsibilities

Provide technical leadership to the Biosense Webster Manufacturing organization in support of the overall pipeline and LCM programs for a $4.0B medical device business.
Facilitates interaction, address engineering issues, prioritizes, and transfer knowledge, as needed, between Product Development, Operations/Manufacturing, Internal Manufacturers, and component/raw material suppliers.
Drive key programs intended to improve our Manufacturing organization such as six sigma certification, design excellence, rotations with manufacturing sites, etc.
Responsible for building capability of organization and leading engineers to build effective Manufacturing Engineering processes at all levels and throughout the company. Develop and mentor Engineers throughout the organization including matrix organizations to create and sustain a strong and diverse talent pipeline.
Steers Collaboration with internal and external partners to drive execution.
Aligns with R&D to drive an overall technology strategy for Biosense Webster.
Reviews and coordinates activities concerned with technical developments and resolves engineering problems.
Manage resources effectively and help prioritize and optimize resource utilization.
Ensure that employees are trained and equipped with the tools to perform their jobs successfully.
Drive best practices in engineering design, automation, and data management.
Develop and manage to expense and capital budgets per our BP and Strat Plan processes.
Ensure compliance in all aspects of Quality and Environmental, Health and Safety per J&J standards.
Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
For those who supervise or manage a staff, 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
Manages a team of Engineers and Technicians.
Is responsible for the complete direction and evaluation of his/her work team.
Directs his/her team according to the applicable policies and laws.
His/her responsibilities include interviewing, hiring, and training employees, planning, assigning, and directing their work, monitoring their development, rewarding and discipline employees, assign complaints and solve conflicts.
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