Sr. Controls Engineer (Liberty)

Sr. Controls Engineer

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 Engineers support 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 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
• Establishes 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.
• 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 procedures
• Works 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 compliance.
• Lead 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 :

The base pay for this position is $75,300.00 $150,700.00. In specific locations, the pay range may vary from the range posted.