Calibrations And Maintenance Engineering Manager.

Calibrations And Maintenance Engineering Manager

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness.

We are searching for the best talent for Calibrations and Maintenance Engineering Manager.

Purpose:

• Directs and coordinates all Calibration and Preventive Maintenance activities and programs.
• Responsible for participating in development support and implementation of transfer plans for new areas/processes.
• Maintains and improves all Business Processes under his/her supervision.
• Ensures that associates under his/her charge have the technical skills and leadership competencies necessary to perform maintenance and calibration routines effectively as well as failure analysis in a safe work environment.
• Ensures the continuous development of maintenance and calibration experts who support the day-to-day activities of the business, as well as its growth.
• Responsible for the harmonization and standardization of maintenance and calibration processes in alignment with strategic business initiatives such as ME2 and Lean Manufacturing.
• Provides support in the day-to-day operations with responsibility / objective of manufacturing at the lowest cost, consistent with quality control specifications.
• Coordinates activities of one or more programs in support of the development of new products for the Business Units. These programs must be related to Calibration and Preventive Maintenance (Plant / Equipment).
• Manages and works on problems of diverse scope where data analysis requires evaluation of identifiable factors; Select methods and techniques for problem solving.
• Directs and coordinates Engineers and Technicians to reach established goals consistent with costs, high quality, profitability and required delivery times.
• Individuals must demonstrate creativity, foresight, and the ability to make judgments, anticipate and solve problems, obtain objectives/requirements, organize/lead projects, and develop standards and guidelines for technical activities.

You will be responsible for:

• The supervision it receives is essentially administrative, with assignments, objectives and limits given in general terms.
• Efficiently manages the use of resources, distributes the workload among the members of his team, maintaining a balance between goals and objectives in the short and long term.
• Execute company goals and objectives, as well as corporate strategies.
• Responsible for the execution of programs/projects as well as the coordination of activities to ensure compliance with corporate goals.
• Maintains cooperation between individuals and areas within or around your organization.
• Implement procedures to ensure that the equipment and machinery meet the required operational performance and utilization. Reviews machinery and equipment requirements based on production schedules.
• Seeking continuous improvement and reduction of downtime and costs from its Preventive Maintenance role.
• Supports the introduction of new products in compliance with operational G&O.
• Fully understands the precepts of the Quality System Regulations (QSR). It makes sure to comply with ISO and QSR regulations.
• Ensures compliance with internal and external audits related to its area of responsibility, as well as timely compliance with any action derived from them.
• Provides and establishes an appropriate climate for the operation within its area of responsibility through the implementation of projects related to continuous improvement and in compliance with the regulations that apply to all aspects of the business.
• Make decisions based on an understanding of multiple departments and the relationship between them.
• Runs its operation to ensure achievement of the CIP and COGS initiatives.
• Understands and implements Signature of Quality (SOQ) methods, Lean Mfg. and Process Excellence (six sigma).
• Provides leadership to face the challenges of Diversity.
• Responsible for the development and implementation of environmental, safety and health programs.

Supervisory responsibilities:

• Manages its Calibration and Maintenance Engineers and Technicians, generating development plans that encourage permanence in the company. It is responsible for all labor matters of its administrative employees.
• Responsible for developing subordinates and encouraging them to use their full potential.
• Is responsible for communicating business-related issues or opportunities to the next level of management.
• 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

Qualifications / Requirements:

Experience and education:

• University degree as a professional in Engineering or related Sciences. Master's degree preferably.
• Six (6) to eight (8) + years of experience preferably in Operations, Manufacturing, Maintenance, Calibration or related activities, preferably in the field of medical products or the pharmaceutical industry.
• Have knowledge about launching new products, and start of operations, knowledge about Quality Assurance requirements, GMP's, Safety and Environment, planning and development of Finance and Human Resources preferably.
• Experience supervising people with technical skills is required.

Required knowledge, skills, abilities, certifications/licenses and affiliations:

• Bilingual English/Spanish
• Skills and general knowledge for financial analysis, budgets, and costs preferably
• Always committed to the values of CREDO, knowledge and compliance with the business process, having visionary leadership.
• Skills in the use of PCs and associated software, preferably knowledge of SAP, Máximo, Windchill.
• Project management skills.
• Ability to effectively manage conflicts and the ability to resolve them diplomatically.
• Ability to translate corporate goals and objectives into successful strategies.
• Responsible for managing and directing equipment for metrological use. Ensures compliance with internal and external metrological management of the plant.
• Ensures that the Calibration and Maintenance processes are followed in accordance with the quality system.
• Provide assistance, audit and advisory services to the departments that require it within the company.
• Guarantee compliance with deadlines and quality, in team management as well as in the administration of certificates/documentation.
• Responsible for maintaining the updating of systems, measurement instruments and external calibrations.
• Complies with the training in his area of responsibility and ensures that his direct employees are trained in his area of responsibility in an allowed period of time.
• Ensures the correct management of the budget for external calibrations.
• Perform validation of calibration templates and methods
• Strong ability to analyze and solve problems, interpersonal relationship skills, negotiation, leadership, ability to interact with associates, technology management, financial analysis.
• Knowledge of products and operations processes.
• Knowledge of the Quality system and document structure procedures preferred.
• Computer skills: Very proficient in word processing programs, spreadsheets, presentations, database applications