MAIN PURPOSE OF ROLE

Provides support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize cost-effective existing manufacturing processes and methods to ensure that production goals are met, in accordance with product specifications and quality standards.

Monitors performance of equipment, recommends and implements improvements to production processes, methods and machines, design tools, and corrects equipment problems or process parameters that could have in resultant non-conforming products, low yields or product quality issues; is also responsible for the activities related to installation and validation of production lines as well as the lifecycle management of equipment.

MAIN RESPONSIBILITIES

• Interfaces with Quality and Research and Development organizations to integrate new products or processes into the existing manufacturing area.

• Initiates and completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company. Prepares reports, publishes, and makes presentations to communicate findings.

• Analyzes and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.

• Understands engineering principles theories, concepts, practices and techniques. Develops knowledge in a field to become a recognized leader or authority in an area of technical specialization and applies this knowledge in leadership roles in the company.

• Incorporates business policies and procedures into task completion. Understands the business needs of the company, and has knowledge of the customer needs of our business. Understands the business cycle and foresight of emerging technologies trends.

• Cultivates internal and external network of resources to complete tasks. Serves as a resource in the selection orientation and training of new engineers and employees. May lead a project team, determining goals and objectives for the projects. Mentors employees by sharing technical expertise and providing feedback and guidance.

• Interacts cross functionally and with internal and external customers. Serves as a consultant for engineering or scientific interpretations and advice on significant matters. Acts as a spokesperson to customers on business unit current and future capabilities.

• Establishes and cultivates an extensive network of support to facilitate completion of assignments.

• Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel.

• May lead a team focused on Yield, MUV, CIP projects of Improvement.

• Participates in determining goals and objectives for engineering responsibilities, projects and direct reports.

• Influences middle management and another functional areas on technical or business solutions.

• May interact with vendors and another Abbott Sites.

• Exercises judgment in selecting innovative, practical methods to achieve problem resolution (DMAIC, A3´s).

• Participate or lead Investigations, CAPA/Divisional CAPA and problem solving.

• May lead a Green Belt and/or Black Belt Projects for CIP, Yield, MUV improvement.

• Create, measure, challenge and Improve Product and Process documentation according Quality Management System.

• Active contribution to understand, connect and improve key process indicators (Yield, MUV, MSP, MPSP, PFM, CIP, etc).

• Develop technical process knowledge in all parts of the product manufacturing cycle, for example: In Catheters in Extrusion, Subassemblies and Main Assembly; In PressureWire in raw material, subassemblies, and finished good.

• Have the ability to develop TLT´s, CO´s, CR´s, Confirmation studies, etc.

• Know, understand and analyze data from JMP, INFINITY to propose process improvements.

• Manage part of the department budget to keep it under the Annual plan.

• Provides training and tutoring for G8, G12 & G14. (Provides guidance to less experienced staff. Acts as a mentor to lower level individual contributors. Influence exerted at peer level and occasionally at first levels of management).

• Prepares product and process reports by collecting, analyzing, and summarizing information and trends.

• Performs installation/validation activities for new or existent production lines, meeting regulatory requirements. That includes equipments, process, product and test method validations.

• Identifies, selects, and purchases equipment/fixtures according to production requirements, due to obsolescence, redundancy or line capacity expansion. Has direct relation with vendors to define equipment suitability.

• Keeps equipment operational by coordinating calibration, maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service when needed.

• Has knowledge and expertise on product requirements and specifications. Understands potential risks related to product malfunctions.

• Assures that production lines output meet the specifications of the product. Has clear criteria of conforming/non conforming product and the test methods used for verifying conformance.

• Maintains manufacturing systems such as SAP routers and BOM's current.

• Maintains procedures current and compliant to regulations. Ensures practices at the manufacturing floor adhere to them.

• Leads or supports local cross functional team activities.

• May supervise and provide technical assistance to non-exempt personnel, being accountable for their correct training and performance management.

• Provides direction and guidance to supervisors, experienced exempt and/or skilled nonexempt levels of employees; evaluates performance of and assists in career development planning for subordinates; often responsible for a local functional or process activity.

• Assignments are expressed in the form of tasks and objectives; generally, makes day-to-day decisions within established guidelines regarding work processes or schedules in order to achieve the program objectives established by senior management; consequences of erroneous decisions would normally result in serious delays to assigned projects or operations with substantial expenditure of time, human resources, and funds, without jeopardizing future business activity.

• Promotes the attainment of group goals by selecting, motivating, and training capable staff. Provides leadership to assigned units by communicating and providing guidance towards achieving group objectives.

• Schedules human and material resources within a group or section in conjunction with near-term plans to ensure their availability; carries out operations within an established budget.

• Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.

• Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.

• Monitors daily work operations and provides direction and guidance to lower-level supervisors, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.

• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc).

• Monitors internal and external indicators by reviewing reports and newsletters, reading organizational literature, meeting with peers and reading departmental reports.

• Contributes to the development and monitoring of area budget through regular analysis of cost and spending.

QUALIFICATIONS

Bachelor's degree in Industrial,  Mechanical, Electrical, Science Engineer or related careers.

5-7 years or an equivalent combination of education and work experience.

• Of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience.
• Wide application of technical principles, practices, and procedures.
• Strong understanding of business unit functions and cross group dependencies/relationships.
• Will perform this job in a quality system environment.
• Experience leading a team toward departmental goals; Safety, Quality, Delivery and Cost.
• Demonstrated understanding of how division and site strategy and objectives connect to day to day activity.
• Computer software knowledge (Microsoft Word, Excel, Power Point).
• Knowledge of Statistical techniques (DOE, SPC) is required.

  Advanced commands of English /  Required

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