Sr. Controls Engineer

Sr. Controls EngineerAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.The Sr. Controls Engineer position works out of our Liberty, SC location in the Cardiac Rhythm Management Division.As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats.Sr. Controls Engineer supports production and process development from concept through sustained manufacturing of FDA regulated products. Responsible for production support, maintenance support, performing process development and qualification, equipment specification, acquisition, installation, and integration.What You'll Work On:Interface with internal customers to provide controls support for manufacturing and testing equipmentSupport the development and maintenance of automated equipment.Evaluate process and design alternatives based on Design for Manufacturability principles.Establish knowledge base of new developments in manufacturing and design technologies.Interface with vendors on procuring materials, services, and equipmentTroubleshoot new and existing automated equipmentAssemble and evaluate automated equipmentEstablishes machine specifications.Support equipment validationsSupport all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.Evaluates machine logic, electromechanical systems and process controls to troubleshoot equipment.Strong knowledge and experience in industrial robotics, Servos, Pneumatic systems, sensors, and Machine Vision systems.Routinely has direct contact with outside consultants, technical staff from key suppliers and engineering staff in other divisions.Strong mechanical and electrical aptitude.Coordinate and participate in equipment Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT), etc.Hands on working knowledge of automation control software and PLC programming and troubleshooting.Familiarity with qualification and regulatory requirements in the medical device industry, including Design Review, User Requirement Specifications (URS), IQ/OQ/PQ, etc.Conceptualize, design, and build complete solutions for novel or complex problems; explore multiple alternatives.Evaluation of machine logic and controls to troubleshoot equipment and identify process improvement opportunities.Programming and integration of controls hardware and software into new and existing manufacturing equipment.Analyzes current equipment for process suitability and provides detailed plans for improvement.Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to ensure compliant, efficient and safe proceduresWorks with other engineers and technicians in developing solutions and improvements in materials, equipment and process as necessary.Actively participates in teams as necessary to ensure continual improvement, safety and complianceLead cross functional project teams and coordinate activities.Analyzes, creates and implements manufacturing and/or business process improvements that increase capacity, reduce lead-time, reduce work in process and improve the quality, cost and delivery performance of Abbott.Identifies opportunities and drives incorporation of appropriate Lean tool usage such as 5S, time study, line balancing, standard work, material flow and value stream mapping, process mapping and Kaizen event into the daily functions of continuous improvement.Investigate and resolve existing equipment operating, reliability, and yield issues and implement corrections or modifications to ensure systems operate within qualified parameters. Create and execute Quality System records to ensure equipment performance history is properly documented.Required Qualifications:Associates Degree Related with 10-15 years relevant experience Or an equivalent combination of education and work experience.Bachelors Degree Engineering OR an equivalent combination of education and work experience.Minimum 5 years5-10 years as automation controls engineer.Must have experience with designing and fabricating automated production equipment for low and high volume processes. Good communication skills and the ability to interact with all levels of the organization. Experience with general automation and control concepts along with machine vision systems and PLC software programming.Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to travel, including internationally.Preferred Qualifications:•Proficient in Microsoft Word, Excel, PowerPoint, Microsoft Project, and Microsoft Outlook. SAP a plus •Detail oriented with strong analytical, organizational, and problem-solving skills. •Demonstration of strong interpersonal communication and presentation skills. •Experience with equipment specification and procurement with emphasis on process and packaging manufacturing solutions, small volume liquid filling, capping, torqueing, label printing, application and inspection systems. •Familiarity with qualification and regulatory requirements in the medical device industry, including Design Review, User Requirement Specifications (URS), FAT, SAT, IQ/OQ/PQ, etc. •Strong commitment to safety and environmental issues. Willingness to adhere to all safety and health rules, plant rules, procedures and guidelines. •Ability to communicate effectively and engage cross functional team on all aspects and responsibilities required of equipment installation and qualifications. •Must be able to work without direct supervision to accomplish goals and meet schedules. •Proven solid work ethic and ability to work well with others as well as independently. •Strong problem-solving and troubleshooting skills.