Manufacturing Process Engineer I

Abbott; Scarborough (ME); On-site; USD 51,000 - 101,000; Full time

Benefits offered by this job

Career development

Free medical coverage HIP PPO

Strong retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott Rapid Diagnostics in Scarborough, ME, seeks a Manufacturing Process Engineer I to oversee manufacturing equipment and process improvements. The role focuses on developing, validating, and continuously improving manufacturing processes while ensuring quality and regulatory compliance.

You will collaborate with cross-functional teams to enhance performance and support new equipment and materials introductions.

Qualifications

• Bachelor's degree (BS) in Mechanical Engineering or equivalent.
• 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.

Responsibilities

• Design and develop new manufacturing processes and equipment; include verification and validation.
• Conduct testing, collect data, and support DOE analyses.
• Support startup, qualification, and validation of new equipment and processes.
• Participate in technical design reviews for process equipment and product designs.
• Maintain Quality System effectiveness and support CAPA activities.
• Evaluate raw material specs to ensure proper controls for manufacturing.

Skills

Multitasking

Self-Motivated

Analytical Thinking/Problem Solving

Verbal & Written Communication

Teamwork & Collaboration

Technical Aptitude

Mathematical Aptitude

Data Analytics

Education

Bachelor's degree in Mechanical Engineering

Tools

Excel

PowerPoint

Power BI

Minitab

JMP

Job description

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 115,000 colleagues serve people in more than 160 countries.

Manufacturing Process Engineer I

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 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.

What You’ll Work On

• 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.

General Competencies

• 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.

Engineering Competencies

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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)

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives : www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

Divisional Information

Diagnostics

We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology.

The base pay for this position is $50,700.00 – $101,300.00. In specific locations, the pay range may vary from the range posted.