Senior Manufacturing Process Engineer: Process & Equipment Optimization

Abbott; United States; On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Free health coverage via HIP PPO

Tuition reimbursement/education

Competitive retirement plan

Job summary

Abbott Rapid Diagnostics is seeking a Senior Manufacturing Process Engineer in Scarborough, Maine to lead manufacturing equipment initiatives and drive quality, productivity, and cost improvements across the operation. The Senior Manufacturing Process Engineer will identify and implement process and material improvements to enhance manufacturing efficiency and support new product development.

You will collaborate with cross-functional teams and ensure compliance with FDA, ISO, cGMP, and QMS

Qualifications

• Responsible for exhibiting professional behavior with internal and external business partners that reflects positively on the company and is consistent with company policies and practices.
• Understand and maintain awareness of the quality and compliance implications associated with the performance of assigned responsibilities.

Responsibilities

• Own and maintain manufacturing processes, ensuring alignment with product specifications, process capabilities, and test method requirements.
• Lead process and equipment improvement initiatives to enhance quality, efficiency, throughput, and cost performance.
• Evaluate and implement manufacturing and design alternatives using Design for Manufacturability (DFM) principles.
• Solve complex technical challenges using structured problem-solving methodologies, statistical tools, and data-driven decision making.
• Design and execute engineering studies, including DOE methodologies, to support process optimization and validation activities.
• Lead equipment implementation, startup, qualification, and process validation activities, including IQ/OQ/PQ protocol development and execution.
• Ensure compliance with Design Controls, Process Validation requirements, FDA regulations, ISO standards, cGMP requirements, and internal Quality Management System (QMS) processes.

Job description

Abbott Rapid Diagnostics is seeking a Senior Manufacturing Process Engineer in Scarborough, Maine to lead manufacturing equipment initiatives and drive quality, productivity, and cost improvements across the operation. The Senior Manufacturing Process Engineer will identify and implement process and material improvements to enhance manufacturing efficiency and support new product development.

You will collaborate with cross-functional teams and ensure compliance with FDA, ISO, cGMP, and QMS