Sr. Controls Engineer

JOB DESCRIPTION The Sr. Controls Engineer position is based in Liberty, SC within the Cardiac Rhythm Management Division of Abbott’s Cardiac Rhythm Technologies. RESPONSIBILITIES Interface with internal customers to provide controls support for manufacturing and testing equipment. Support 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 equipment. Troubleshoot new and existing automated equipment. Assemble and evaluate automated equipment. Establish machine specifications. Support equipment validations. Support all company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Evaluate 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. Programming and integration of controls hardware and software into new and existing manufacturing equipment. Analyze current equipment for process suitability and provide detailed plans for improvement. Create and revise 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 procedures. Work with other engineers and technicians in developing solutions and improvements in materials, equipment and process as necessary. Actively participate in teams as necessary to ensure continual improvement, safety and compliance. Lead cross‑functional project teams and coordinate activities. Analyze, create and implement 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. Identify opportunities and drive incorporation of appropriate Lean tools such as 5S, time study, line balancing, standard work, material flow and value stream mapping, process mapping and Kaizen events 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 Associate’s Degree related with 10‑15 years relevant experience OR an equivalent combination of education and work experience. Bachelor’s Degree in Engineering OR an equivalent combination of education and work experience. Minimum 5 years of experience. 5‑10 years as an automation controls engineer. 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. Strong verbal and written communication skills with the ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in a 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. 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. LOCATION & DETAILS Location: United States – Liberty: 253 Financial Blvd. Shift: Standard Travel: Yes, 5% of the time Medical Surveillance: No Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8‑hour day), work in a clean room environment. Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: EEO is the Law link - Espanol: #J-18808-Ljbffr