Senior Automation Engineer

Senior Automation 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 OpportunityAbbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.The position of Senior Manufacturing Automation Engineer is within our Infectious Disease Business Unit located in Scarborough, Maine. This role will be responsible for supporting manufacturing processes, quality/cost savings initiatives and implementation of engineering principles while assuring compliance with cGMP quality and safety standards.What You'll Work OnResponsible for equipment specification, acquisition, and implementation.Leads automation equipment upgrade efforts related to safety, obsolescence, and continuous improvement initiatives.Evaluates machine logic, electromechanical and process controls to troubleshoot equipment and drives to resolution.Leads teams to identify root cause of manufacturing failures using structured problem solving. Applies root cause fixes to prevent recurrence.Conducts failure modes and effects analysis and evaluates manufacturing equipment risk.Completes complex projects based on comprehensive knowledge of manufacturing equipment and processes.Leads design of experiments, validation, completion of testing and analysis of data. Presents data to cross functional teams.Drives implementation of new methods or materials for continual improvement of quality and efficiency.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.Leads other engineers and technicians in developing solutions and improvements in materials, equipment, and process as necessary in addition to ensuring continual improvement, safety, and compliance.Manages cross-functional project teams and coordinate activities.Provides training and process expertise for product processing in specific areas such as process development, tooling development, documentation, cleaning protocol, process characterization and validation.Initiates and leads to resolution of Quality Incidents and CAPA.Participates in teams as necessary and mentor's junior engineers and maintenance technicians to ensure continual improvement, safety, and compliance.Considers safety, ergonomic, maintenance, and operator impact on manufacturing design.Interacts with the local Project Management Office on milestones and project status updates.Participates in site strategy meetings and planning.Leads change through Agile PDM.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.Carries out duties in compliance with established business policies and procedures.Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.Support department by performing related tasks as requested.Core CompetenciesIndependently identifies and drives innovative automation solutions to complex technical and operational challenges within diagnostics manufacturing and development environments. Applies systems thinking to improve processes, reliability, scalability, and compliance, while partnering with stakeholders to evaluate risks and implement sustainable improvements.Effectively manages multiple high?impact initiatives concurrently by prioritizing work across automation development, validation support, troubleshooting, and continuous improvement activities. Demonstrates strong organizational skills while meeting aggressive timelines in regulated environments.Demonstrates a high degree of self?motivation and accountability, taking ownership of automation systems and technical deliverables from concept through deployment and sustainment. Drives personal and team objectives with minimal supervision while serving as a technical resource and mentor to others.Clearly communicates complex technical concepts, risks, and recommendations to diverse audiences including engineers, quality, manufacturing, IT, and leadership. Produces clear technical documentation, protocols, and reports aligned with diagnostic, quality, and regulatory requirements.Works collaboratively across engineering, manufacturing, quality, regulatory, and external vendors to deliver compliant automation solutions. Builds trust through technical credibility, respects diverse perspectives, and aligns automation strategies with business and diagnostic product goals.Technical CompetenciesDemonstrates advanced proficiency in industrial automation and control systems, including PLCs, HMIs, robotics, vision systems, sensors, and integrated manufacturing equipment used in diagnostics production or laboratory environments.Applies strong knowledge of fabrication and mechanical principles—including CNC machining, milling, welding, mechanical assemblies, and bolted connections—to support the design, modification, and integration of automated systems and test equipment.Applies technical knowledge within regulated diagnostics or life sciences environments, ensuring automation solutions align with applicable quality system requirements, validation expectations, and Good Manufacturing Practices (GMP).Utilizes mathematical and statistical concepts such as ANSI/AQL, probability, process capability, and basic statistical analysis to support equipment performance evaluation, test method development, and continuous improvement initiatives.Interprets complex technical instructions, specifications, and schematics in mathematical, electrical, and mechanical formats. Diagnoses and resolves automation and equipment issues involving multiple abstract and concrete variables.Experienced in computer?aided design (CAD) and manufacturing software to design, review, and modify automated system layouts, mechanical components, and equipment integrations.Demonstrates proficiency in materials testing, metrology, and measurement systems used to evaluate material properties, system performance, and diagnostic product integrity in automated or semi?automated processes.Required QualificationsBachelor's degree (BS) in engineering or equivalent combination of education and experience.7+ years engineering experience in a manufacturing environmentExperience in the application of lean six sigma principles and the DMAIC approach or a similar structured problem-solving system.Proficiency in change management principles and processes.Preferred Qualifications:Prior experience working in a company operating under ISO, FDA, or similar quality systems or regulations.Experience working in a GMP, FDA, ISO and USDA regulated environment.Experience in cGMP and ISO 13485 regulations and practices.Experience in statistical analysis software.Experience in Microsoft Suites software. (Microsoft Excel, PowerPoint, Power BI, etc.)The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.