Manufacturing Process Engineer I

Abbott • Scarborough, ME

1d • $50,700 - $101,300 • Onsite

About The Position

The position of Manufacturing Process Engineer I is within our Infectious Disease Business Unit located in Scarborough, ME. This role will be responsible for all Manufacturing Equipment and equipment quality/cost savings initiatives, improving efficiency through material and process improvement, reducing material processing costs, and participating in new product design. As a Manufacturing Process Engineer I, you will support the development, validation, and continuous improvement of manufacturing processes while ensuring compliance with quality and regulatory requirements. You will collaborate with cross-functional teams to enhance operational performance, drive process improvements, and support the successful introduction of new equipment and materials.

Requirements

• Bachelor's degree (BS) in Mechanical Engineering or 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.
• Multitasking: Effectively manages multiple priorities while maintaining accuracy, productivity, and meeting deadlines.
• Self-Motivated: Demonstrates initiative, works independently, and pursues continuous learning and improvement.
• Analytical Thinking/Problem Solving: Evaluates complex situations, identifies root causes, and develops effective solutions.
• Verbal & Written Communication: Clearly communicates ideas and information to technical and non-technical audiences.
• Teamwork & Collaboration: Works effectively across teams, builds strong relationships, and supports shared goals.
• Technical Aptitude: Ability to interpret technical instructions, engineering drawings, specifications, and process documentation.
• Mathematical Aptitude: Knowledge of ANSI/AQL, probability, statistics, and sampling methodologies.
• Data Analytics: Experience collecting, analyzing, and interpreting data to support decision-making, process improvement, and statistical analysis.

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 in Microsoft Suites software. (Excel, PowerPoint, Power BI, etc.)
• Exposure to statistical analysis software. (Minitab or JMP preferred)

Responsibilities

• Assist in the design and development of new manufacturing processes and equipment, including process verification and validation activities.
• Conduct testing, collect and organize data, and support the analysis of engineering studies, including Design of Experiments (DOE).
• Support the startup, qualification, and validation of new manufacturing equipment and processes.
• Participate in technical design reviews for process equipment, product designs, and requirements documentation.
• Utilize and maintain the effectiveness of the Quality System, including supporting Quality Incident investigations, CAPA activities, and corrective actions.
• Analyze raw material specifications to ensure appropriate requirements and controls are in place to support manufacturing operations.
• Evaluate company-initiated raw material changes and coordinate testing, validation, and implementation activities as required.
• Identify, recommend, and support new methods, technologies, and materials to improve product quality, process efficiency, and operational performance.
• Create, revise, and maintain manufacturing documentation, including specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and other technical documents to support compliant, efficient, and safe manufacturing processes.
• Ensure compliance with FDA regulations, applicable regulatory requirements, company policies, operating procedures, and established processes.
• Build and maintain positive working relationships with employees, customers, contractors, and vendors at all levels of the organization.
• Carry out responsibilities in accordance with established business policies, procedures, and quality standards.
• Demonstrate commitment to the development, implementation, and effectiveness of quality processes in support of ISO, FDA, and other regulatory requirements.
• Exhibit professionalism in all interactions with internal and external business partners, reflecting Abbott's values, policies, and practices.
• Understand and maintain awareness of the quality and compliance impact associated with the performance of assigned responsibilities.
• Provide additional departmental support and perform related duties as assigned.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

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