Manufacturing Process Engineer I

2010 Abbott Diagnostics Scarborough, Inc.; Scarborough (ME); On-site; USD 51,000 - 101,000; Full time

Benefits offered by this job

Free medical coverage

Strong retirement plan

Tuition reimbursement

Education benefits

Job summary

Abbott Scarborough, ME is seeking a Manufacturing Process Engineer I to drive equipment and process improvements in the Infectious Disease Diagnostics division. The role focuses on cost savings, efficiency, and support for new product design across the manufacturing floor.

The candidate will work under cGMP/ISO 13485 guidelines, with a BS in engineering and experience in manufacturing. Abbott offers strong benefits and a structured professional growth path in a global organization.

Qualifications

• Bachelor's degree in Engineering or equivalent.
• Familiarity with cGMP and ISO 13485.
• Exposure to mechanical, biomedical, industrial or chemical engineering.
• Knowledge of engineering principles and industry standards.
• Preferred: experience with ISO/FDA quality systems.

Responsibilities

• Carry out duties in compliance with established policies and procedures.
• Contribute to the development, implementation and effectiveness of Quality Processes per ISO, FDA, and other regulatory agencies.
• Develop and improve manufacturing processes and equipment; assist in process verification and validation.
• Conduct tests, collect and format data, and assist in DOE analysis.
• Assist in start-up of new equipment and validation protocols.
• Create and revise manufacturing documents, SOPs, safety instructions and validation protocols.

Skills

cGMP awareness

ISO 13485

Engineering principles

Biomedical engineering

Analytical thinking

Education

Bachelor's degree in Engineering

Tools

Excel

Power BI

Minitab

JMP

Job description

JOB DESCRIPTION

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

The Manufacturing Process Engineer I works out of our Scarborough, ME location in the Infectious Disease, Diagnostics Division. 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. The Manufacturing Process Engineer I 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.

What You’ll Work On

• Carries out duties in compliance with established business policies and procedures.
• Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
• Support department by performing related tasks as requested.
• Assists in designing or developing new manufacturing processes and equipment and assists in process verification and validation.
• Conduct tests, collect and format data, and assist in analysis of engineering studies (DOEs).
• Assists in the start-up of new equipment and execution of validation protocols.
• Participates in technical design reviews for process equipment and product design and requirements documents.
• Responsible for utilizing and maintaining the effectiveness of the quality system, including supporting Quality Incidents and CAPA investigations and actions.
• Analyzes raw material specifications to ensure appropriate features and limits are in place to support company manufacturing process.
• Evaluates company initiated raw material changes and coordinates appropriate testing and validation as required.
• Suggests and supports new methods or materials for continual improvement and optimization in the quality or efficiency of a product or process.
• Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and other technical documents to ensure compliant, efficient, and safe processes.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Bachelor's degree (BS) in 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).

COMPETENCIES

General Competencies:

• Multitasking: Demonstrates the ability to handle multiple tasks or responsibilities simultaneously by efficiently managing time, prioritizing tasks, and maintaining productivity across different activities
• Self-Motivated: Demonstrates a proactive attitude, consistently drives personal and team goals, seeks avenues of learning and growth, and maintains high productivity with minimal external supervision.
• Analytical Thinking/Problem Solving: The ability to dissect a situation, issue, or problem into smaller components or trace its implications methodically.
• Verbal and Written Communication: Effectively conveys ideas in both individual and group settings, adapting style and methods to suit the audience’s needs, both verbally and in writing.
• Teamwork and Collaboration: Demonstrates professional cooperation by working together harmoniously with others, being an integral part of a team, respecting others’ contributions, and aligning personal goals with those of the team.

Technical Competencies:

• Technical Aptitude: Exposure to interpreting an extensive variety of technical instructions in mathematical or diagram form and dealing with several abstract and concrete variables.
• Mathematical Aptitude: Experience in working with mathematical concepts such as ANSI/AQL, probability, and statistics.
• Data Analytics: Experience in Data Analytics, understanding of data sources, compiling,statistical analysis, and sampling plans.

Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers

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.

JOB FAMILY: Engineering

DIVISION: ID Infectious Disease

LOCATION: United States > Scarborough : 10 Southgate Rd

ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Wear ear plugs, Work in a clean room environment, Work in noisy environment

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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