Manufacturing Process Engineer I

Abbott • Scarborough, ME

1d • $50,700 - $101,300 • Onsite

About The Position

The Manufacturing Process Engineer I works at Abbott’s Scarborough, Maine location in the Infectious Disease, Diagnostics Division. The role supports manufacturing equipment and equipment quality and cost-savings initiatives, improves efficiency through material and process improvements, reduces material processing costs, and participates in new product design. The engineer assists with developing manufacturing processes and equipment, process verification and validation, equipment start-up, and engineering studies. The role also supports Abbott’s quality system and compliance with applicable regulatory requirements, including ISO and FDA requirements.

Requirements

• Bachelor’s degree in Engineering, or an equivalent combination of education and experience.
• Familiarity with cGMP and ISO 13485 regulations and practices.
• Exposure to mechanical, biomedical, industrial, or chemical engineering.
• Knowledge of engineering principles, methodologies, and industry standards.
• Ability to handle multiple tasks, manage time, and prioritize responsibilities.
• Proactive, self-motivated approach to goals, learning, and growth.
• Analytical thinking and problem-solving ability.
• Effective verbal and written communication skills.
• Ability to work collaboratively and professionally as part of a team.
• Exposure to interpreting technical instructions in mathematical or diagram form and handling abstract and concrete variables.
• Experience working with mathematical concepts such as ANSI/AQL, probability, and statistics.
• Experience in data analytics, including understanding data sources, compiling data, statistical analysis, and sampling plans.

Nice To Haves

• Prior experience working in a company operating under ISO, FDA, or similar quality systems or regulations.
• Exposure to cGMP and ISO 13485 regulations and practices.
• Experience with Microsoft software such as Excel, PowerPoint, and Power BI.
• Exposure to statistical analysis software; Minitab or JMP preferred.

Responsibilities

• Carry out duties in compliance with established business policies and procedures.
• Support the development, implementation, and effectiveness of applicable quality processes in accordance with ISO, FDA, and other regulatory requirements.
• Exhibit professional behavior with internal and external business associates consistent with company policies and practices.
• Understand and maintain awareness of the quality consequences that may result from improper job performance.
• Perform related tasks as requested to support the department.
• Assist in designing or developing new manufacturing processes and equipment, and assist with process verification and validation.
• Conduct tests, collect and format data, and assist in analyzing engineering studies, including DOEs.
• Assist with start-up of new equipment and execution of validation protocols.
• Participate in technical design reviews for process equipment and product design and requirements documents.
• Support the quality system, including Quality Incident and CAPA investigations and actions.
• Analyze raw material specifications to ensure appropriate features and limits support manufacturing processes.
• Evaluate company-initiated raw material changes and coordinate required testing and validation.
• Suggest and support new methods or materials to improve and optimize product or process quality and efficiency.
• Create and revise manufacturing documents, specifications, SOPs, safety instructions, validation protocols, risk assessments, and other technical documents.
• Comply with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive, cooperative communications and collaboration with employees, customers, contractors, and vendors at all levels.

Benefits

• Career development opportunities with an international company.
• Employees may qualify 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 providing an affordable and convenient path to a bachelor’s degree.
• Health and wellness benefits.

What This Job Offers

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