Manufacturing Automation Engineer I

Abbott•Scarborough, ME
•$50,700 - $101,300•Onsite

About The Position

The Manufacturing Automation Engineer I works at Abbott’s Scarborough, Maine location in the Infectious Disease, Diagnostics Division. The role supports manufacturing process improvements and quality and cost-savings initiatives while ensuring compliance with current good manufacturing practices (cGMP), quality, safety, and regulatory requirements. The engineer assists with evaluating automation machine logic, electromechanical systems, and process controls to troubleshoot equipment; identifying manufacturing failure root causes; conducting failure modes and effects analyses; and assessing equipment risk. The role supports experiments, validation, testing, data analysis, and continuous improvement, and evaluates equipment suitability to develop improvement plans. It also contributes to manufacturing solutions, technical documentation, change management through Agile PDM, and training technicians and operators on standard operating procedures. The position requires collaboration across teams and compliance with FDA regulations, company policies, operating procedures, and applicable quality systems.

Requirements

  • Bachelor’s degree in Engineering or an equivalent combination of education and experience.
  • Familiarity with cGMP and ISO 13485 regulations and practices.
  • Exposure to engineering in a manufacturing environment.
  • Knowledge of engineering principles, methodologies, and industry standards.
  • Exposure to Programmable Logic Controller programming and troubleshooting.
  • Ability to read and trace machine control systems from electrical prints and troubleshoot simple control hardware such as relays, fuses, and breakers.
  • Experience interpreting engineering drawings and schematics.
  • Experience communicating complex technical information in writing.

Nice To Haves

  • Prior experience in a company operating under ISO, FDA, or similar quality systems or regulations.
  • Exposure to GMP, FDA, ISO, and USDA regulated environments.
  • Exposure to cGMP and ISO 13485 regulations and practices.
  • Exposure to Lean Six Sigma principles, DMAIC, or a similar structured problem-solving system.
  • Exposure to statistical analysis software.
  • Exposure to Microsoft Office software, including Excel, PowerPoint, and Power BI.
  • Allen Bradley PLC experience is preferred.
  • Exposure to fabrication principles such as CNC, lathe, milling, welding, and bolted connections.
  • Exposure to CAD and manufacturing software for designing system layouts.

Responsibilities

  • Carry out duties in compliance with established business policies and procedures.
  • Support the development, implementation, and effectiveness of applicable quality processes in accordance with ISO, FDA, and other regulatory requirements.
  • Maintain professional conduct and positive, cooperative communications with employees, customers, contractors, and vendors.
  • Understand and maintain awareness of quality consequences that may result from improper job performance.
  • Perform related departmental tasks as requested.
  • Assist in evaluating automation machine logic, electromechanical systems, and process controls to troubleshoot equipment.
  • Assist in identifying root causes of manufacturing failures using structured problem-solving.
  • Assist with Failure Modes and Effects Analysis and evaluation of manufacturing equipment risk.
  • Support design of experiments, validation, testing, and data analysis for continuous improvement.
  • Analyze equipment for process suitability and develop detailed improvement plans.
  • Support engineers and technicians in developing solutions and improvements to materials, equipment, and processes.
  • Support creation and revision of manufacturing documents, specifications, SOPs, safety instructions, validation protocols, risk assessments, procedures, and other technical documents.
  • Participate in teams to support continual improvement, safety, and compliance.
  • Consider safety, ergonomics, maintenance, and operator impact in manufacturing design.
  • Train technicians and operators on Standard Operating Procedures.
  • Support management of changes through Agile PDM.
  • Comply with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.

Benefits

  • Career development opportunities with an international company.
  • Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • Retirement savings plan with a high employer contribution.
  • Tuition reimbursement.
  • Freedom 2 Save student debt program.
  • FreeU education benefit, an affordable and convenient path to earning a bachelor’s degree.
  • Health and wellness benefits.
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