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.
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.
May lead a team focused on Yield, MUV, CIP projects of Improvement.
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.
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.
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.
Bachelor's degree Industrial,Mechanical, Electrical, Science Engineer or related careers.
0-2 years or an equivalent combination of education and work experience.
Intermediate commands of English
Computer software knowledge (Microsoft Word, Excel, Power Point).
Knowledge of FDA, GMP and ISO guidelines.
Basic technical knowledge of concepts, practices and procedures.
Limited understanding of business unit / group function.
Works under supervision. Work is
Working knowledge of applicable regulations : Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
Experience in deploying risk reduction strategies, such as zero defects, to improve product quality.
Operations experience desirable. Detailed understanding of all operational metrics, such as : Units per hour (UPH), units per person per hour (UPPH), PFM, on time in full (OTIF), master production schedule performance (MPSP), manufacturing schedule