Sr. Equipment and Automation Engineer

Abbott; Madison (WI); On-site; USD 100,000 - 150,000; Full time

Job summary

Abbott in Madison, WI seeks a Sr. Equipment and Automation Engineer to drive design transfers of new medical devices and provide manufacturing support for existing products.

You will participate in design reviews, risk assessments, regulatory documentation, and develop processes for new equipment. This hands-on role emphasizes strong communication and teamwork to improve quality and reliability, with SolidWorks and PDM experience advantageous.

Qualifications

• Experience in mechanical engineering and medical device design transfer.
• Strong documentation, regulatory, and quality system awareness.
• Excellent communication and ability to work cross-functionally.

Responsibilities

• Lead or support new product introductions and design transfers.
• Create documentation records per regulatory and quality requirements.
• Develop processes and procedures for new equipment.
• Maintain SolidWorks parts, drawings, and assembly files.
• Lead design reviews and risk assessments.
• Identify improvement opportunities and analyze data.
• Support manufacturing and repair center activities.
• Ensure compliance with FDA, ISO, CAP, CLIA.

Skills

Mechanical engineering

Design transfer

Cross-functional collaboration

Data analysis

Regulatory compliance

Tools

SolidWorks

SolidWorks PDM

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.

Position Overview

The Sr. Equipment and Automation Engineer is primarily responsible for design transfer of new medical devices and providing manufacturing support for the existing medical devices. This position will participate in a variety of engineering functions, including but not limited to design changes, design reviews, supplier qualifications, risk assessments, and creating proper documentation to support GMP requirements. This is an ideal role for a hands-on mechanical engineer with good communication skills looking to make an impact in the fight against cancer.

Essential Duties

Include but are not limited to the following :

• Lead or support new product introductions, design transfers, and product changes.
• Create documentation records per regulatory and quality requirements.
• Develop processes and procedures for new equipment.
• Create and update Solidworks parts, drawings, and assembly files.
• Maintain the Solidworks PDM library for new and updated files.
• Lead or participate in design reviews and risk assessments.
• Apply defined procedures to execute and document changes to existing equipment.
• Identify, create, document, and execute protocols to support process or part changes.
• Define improvement opportunities, investigate issues, gather facts, analyze data, and draw accurate data-driven conclusions.
• Lead failure analysis investigations, identify root cause analysis, and develop solutions to resolve quality issues in a timely manner.
• Lead or support product non-conforming material reports, corrective and preventative actions, investigations, audits, or complaints. Document in accordance with applicable regulatory requirements.
• Provide subject matter expertise for custom equipment and processes.
• Lead continuous improvement projects.
• Support the building and testing of custom equipment.
• Provide manufacturing support for the repair center.
• Identify opportunities, analyze data, and work with cross functional teams to implement solutions that improve production quality, capability, reliability, or reduce costs.
• Develop project plans, delegate effectively, and execute assigned tasks.
• Prioritize assignments and work independently with minimal guidance from leadership.
• Provide clear and concise documentation and communication of project needs, scope, budget, and status to peers and leadership.
• Follow procedures and maintain detailed records in accordance with FDA, ISO, CAP, CLIA requirements.
• Ability to work independently and as part of a team within a matrix organization.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and