Senior Manufacturing Process Engineer

Abbott • Scarborough, ME

20h • $78,000 - $156,000 • Onsite

About The Position

The Senior Manufacturing Process Engineer is within Abbott Rapid Diagnostics’ Infectious Disease Business Unit in Scarborough, Maine. The role leads manufacturing equipment initiatives and quality, productivity, and cost improvement projects across the operation. It identifies and implements process and material improvements to enhance manufacturing efficiency, reduce production costs, optimize equipment, and support new product development and commercialization.

Requirements

• Bachelor’s degree in Engineering or an equivalent combination of education and experience.
• At least 7 years of engineering experience in a manufacturing environment.
• Technical expertise in Mechanical, Biomedical, Industrial, Chemical, or a related engineering discipline.
• Experience performing engineering calculations, designed experiments, controlled testing, and statistical analysis.
• Proficiency with Microsoft Office applications, including Excel, PowerPoint, and Power BI.
• Experience with change management principles and practices.

Nice To Haves

• Experience in a regulated manufacturing environment operating under FDA, ISO, or comparable quality systems.
• Working knowledge of cGMP requirements and ISO 13485 standards.
• Proficiency with statistical analysis software such as Minitab or JMP.
• Experience with CAD and related engineering software for equipment, tooling, and process design.
• Experience with Quality Management Systems and change control in regulated environments.
• Ability to interpret technical specifications, engineering drawings, schematics, and complex instructions.
• Knowledge of statistical methods, probability concepts, ANSI/AQL sampling plans, and engineering calculations.
• Understanding of manufacturing financial metrics, including COGS, capital investments, inventory management, profitability, and cost reduction.
• Data analytics skills to use manufacturing and quality data for process improvement and business decisions.
• Competencies in multitasking, verbal and written communication, analytical thinking and problem solving, strategic planning, and vendor management.

Responsibilities

• Own and maintain manufacturing processes to ensure alignment with product specifications, process capabilities, and test method requirements.
• Lead process and equipment improvements to enhance quality, efficiency, throughput, and cost performance.
• Evaluate and implement manufacturing and design alternatives using Design for Manufacturability principles.
• Solve technical challenges using structured problem-solving methods, statistical tools, and data-driven decision-making.
• Design and execute engineering studies, including Design of Experiments, for process optimization and validation.
• Lead equipment implementation, startup, qualification, and process validation, including development and execution of IQ/OQ/PQ protocols.
• Ensure compliance with Design Controls, Process Validation requirements, FDA regulations, ISO standards, cGMP requirements, and internal Quality Management System processes.
• Support Quality Incidents and CAPA investigations, perform root cause analysis, and implement corrective and preventive actions.
• Analyze raw material specifications and lead evaluations, testing, and validation associated with material changes.
• Develop, revise, and maintain manufacturing documentation, including SOPs, work instructions, specifications, validation protocols, risk assessments, and engineering procedures.
• Conduct audits and assessments for regulatory, quality, and operational compliance.
• Lead technical reviews for manufacturing equipment, process changes, product design, and engineering requirements.
• Research and implement manufacturing technologies and engineering solutions to improve operational performance.
• Drive change management through Agile PLM/PDM systems and established engineering change processes.
• Collaborate with Manufacturing, Quality, R&D, Supply Chain, Maintenance, and Regulatory Affairs.
• Mentor and provide technical guidance to engineers and technicians.
• Comply with applicable FDA, ISO, environmental, safety, company, and OSHA requirements.
• Support continuous improvement initiatives and organizational quality, operational, and business objectives.
• Exhibit professional behavior with internal and external business partners, understand quality and compliance implications of assigned work, support departmental objectives, and perform other related duties as assigned.

Benefits

• Potential eligibility 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 a bachelor’s degree.
• Career development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior