Senior Manufacturing Process Engineer

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.

JOB DESCRIPTION:

Senior Manufacturing Process Engineer

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• •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.

The Opportunity

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of Senior Manufacturing Process Engineer is within our Infectious Disease Business Unit located in Scarborough, Maine . This role is responsible for leading manufacturing equipment initiatives and driving quality, productivity, and cost improvement projects across the operation. The Senior Manufacturing Process Engineer will identify and implement process and material improvements to enhance manufacturing efficiency, reduce production costs, support equipment optimization, and contribute to new product development and commercialization efforts.

What You’ll Work On

• •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.
• •Support Quality Incidents, CAPA investigations, root cause analysis, and implementation of corrective and preventive actions.
• •Analyze raw material specifications and lead evaluations, testing, and validation activities 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 to ensure compliance with regulatory, quality, and operational standards.
• •Lead technical reviews for manufacturing equipment, process changes, product design, and engineering requirements.
• •Research and implement new manufacturing technologies and engineering solutions to improve operational performance.
• •Drive change management activities through Agile PLM/PDM systems and established engineering change processes.
• •Collaborate effectively with cross-functional teams, including Manufacturing, Quality, R&D, Supply Chain, Maintenance, and Regulatory Affairs.
• •Mentor and provide technical guidance to engineers and technicians to support continuous improvement, compliance, and operational excellence.
• •Ensure compliance with all applicable FDA, ISO, environmental, safety, and company policies, including OSHA requirements.
• •Support continuous improvement initiatives and organizational objectives in support of quality, operational, and business goals.

Required 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.
• •Support departmental objectives and perform other related duties as assigned.
• •Bachelor's degree in Engineering or an equivalent combination of education and experience.
• •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.

Preferred Qualifications

• •Experience working 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.

Competencies

General Competencies

• •Multitasking: Effectively manages multiple priorities simultaneously by balancing workload, organizing competing demands, and maintaining productivity in a fast-paced environment.
• •Verbal and Written Communication: Communicates complex technical information clearly and effectively to diverse audiences through both verbal and written channels.
• •Analytical Thinking & Problem Solving: Identifies root causes, evaluates alternatives, and develops practical solutions to complex technical and operational challenges.
• •Strategic Planning: Develops and executes short- and long-term plans that align with business objectives, drive operational improvements, and support cross-functional collaboration.
• •Vendor Management: Builds and manages relationships with suppliers and service providers to ensure quality, reliability, cost-effectiveness, and continuous improvement.

Technical Competencies

• •Technical Aptitude: Demonstrates the ability to interpret technical specifications, engineering drawings, schematics, and complex instructions while managing multiple variables and constraints.
• •Mathematical Aptitude: Applies statistical methods, probability concepts, ANSI/AQL sampling plans, and engineering calculations to support decision-making and process improvements.
• •Financial Acumen: Understands manufacturing financial metrics, including Cost of Goods Sold (COGS), capital investments, inventory management, profitability, and cost reduction initiatives.
• •Data Analytics: Collects, analyzes, and interprets manufacturing and quality data using statistical techniques to drive process improvements and support business decisions.
• •CAD: Experience using computer-aided design (CAD) and related engineering software to support equipment, tooling, and process design activities.
• •Quality Management Systems (QMS): Experience working within Quality Management Systems and managing change control processes in regulated environments.

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