• AME Automation Engineer

    GE HealthCare (Waukesha, WI)


    Job Description Summary

    We are seeking a detail-oriented and innovative Automation Engineer to join our Advanced Manufacturing Engineering (AME) team within a regulated medical device manufacturing environment. This role is responsible for designing, developing, and implementing automation solutions that enhance manufacturing efficiency, ensure product quality, and maintain compliance with FDA and ISO standards. The ideal candidate will have experience in highly regulated industries and a passion for advancing healthcare through precision engineering.

    Job Description

    Key Responsibilities:

    + Design and implement automated systems including robotics, PLCs, HMIs, and vision systems to support medical device production.

    + Lead the development and validation of automated equipment in compliance with internal quality systems

    + Collaborate with Design Engineering, Quality, and Manufacturing teams to ensure automation solutions align with product and process requirements.

    + Generate and maintain documentation such as ERS, FAT/SAT protocols, Equipment Qualifications, and risk assessments.

    + Lead equipment qualification and process validation activities.

    + Drive continuous improvement initiatives focused on safety, quality, and efficiency.

    + Troubleshoot and resolve issues with automated systems and provide technical support to production teams.

    + Stay current with emerging automation technologies and regulatory requirements.

    Qualifications:

    + Bachelor’s degree in Electrical Engineering, Mechanical Engineering, Mechatronics, or a related field.

    + 3+ years of experience in automation engineering, preferably in medical device or pharmaceutical manufacturing.

    + Proficiency in PLC programming (e.g., Omron, Allen-Bradley, Siemens), robotics integration, and industrial communication protocols (e.g., OPC UA, Modbus, Ethernet/IP). and HMI development.

    + Experience with automated inspection systems (e.g., machine vision, laser measurement, 3D scanning).

    + Experience with Python, C/C++, or MATLAB for automation scripting and data analysis. Familiarity with GMP, FDA regulations, and ISO standards.

    + Strong analytical, documentation, and problem-solving skills.

    + Excellent communication and cross-functional collaboration abilities.

    + Experience with MES and SCADA systems.

    Preferred Qualifications:

    + Experience with cleanroom automation.

    + Knowledge of data integrity principles and electronic records.

    + Lean Six Sigma certification or experience with process improvement methodologies.

     

    GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf) . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

     

    GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

     

    While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

     

    **Relocation Assistance Provided:** Yes