Manufacturing Automation Engineer I

Abbott; United States; On-site; USD 70,000 - 100,000; Full time

Job summary

Abbott's Scarborough, ME facility seeks a Manufacturing Automation Engineer I to support manufacturing improvements in the Infectious Disease Diagnostics division. You’ll help drive quality, cost savings, and safe operations while ensuring compliance with cGMP, ISO 13485, and FDA regulations in a high‑volume diagnostics environment.

You will analyze processes, troubleshoot automation equipment, participate in risk assessments, support design of experiments, and help develop SOPs and validation

Qualifications

• Bachelor's degree in Engineering or equivalent.
• Familiarity with cGMP and ISO 13485 regulations.
• Exposure to manufacturing engineering in a factory setting.

Responsibilities

• Support manufacturing process improvements and quality/cost savings.
• Assist with evaluating automation logic and process controls.
• Contribute to Failure Modes and Effects Analysis and risk assessments.
• Develop and revise SOPs, validation protocols, and technical documents.
• Provide training to technicians and operators on SOPs and procedures.

Skills

Manufacturing engineering

cGMP knowledge

ISO 13485 knowledge

Problem solving

Education

Bachelor's degree in Engineering

Job description

Abbott 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 122,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The Manufacturing Automation Engineer I works out of our Scarborough, ME location in the Infectious Disease, Diagnostics Division. We're empowering smarter medical and economic decision‑making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.

The Manufacturing Automation Engineer I will be responsible for supporting manufacturing processes improvements, quality/cost savings initiatives while assuring compliance with cGMP, quality, and safety standards.

• 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.
• Assists with evaluating automation machine logic, electromechanical systems and process controls to troubleshoot equipment.
• Assists with identifying root cause of manufacturing failures using structured problem solving.
• Assists with conducting Failure Modes and Effects Analysis and evaluating manufacturing equipment risk.
• Supports design of experiments, validation, completion of testing, and analysis of data for continuous improvement activities.
• Analyzes current equipment for process suitability and provides detailed plans for improvement.
• Supports other engineers and technicians in developing solutions and improvements in materials, equipment, and processes as necessary.
• Supports the creation and revision of 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.
• Participates in teams as necessary to ensure continual improvement, safety, and compliance.
• Assists with considering the safety, ergonomic, maintenance and operator impact on manufacturing design.
• Provides training to technicians and operators on Standard Operating Procedures.
• Supports managing changes 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.

Required Qualifications

• Bachelor's degree (BS) in Engineering or 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.

PREFERRED QUALIFICATIONS

• Prior experience working in a company operating under ISO, FDA, or similar quality systems or regulations.
• Exposure to working in a GMP, FDA, ISO and USDA regulated environment.
• Exposure to cGMP and ISO 13485 regulations and practices.
• Exposure to the application of lean six sigma principles and the DMAIC approach or a similar structured problem-solving system.
• Exposure to statistical analysis software.
• Exposure to Microsoft Suites software. (Micro