Process Engineer III

Abbott Laboratories; Alameda (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Health coverage

Tuition reimbursement

Education benefits

Retirement plan

Job summary

Abbott Diabetes Care in Alameda, CA is seeking a Process Engineer III to support manufacturing equipment and processes. This role drives cost reductions, improves quality, and scales production in a regulated setting.

You will design, verify, and validate processes, lead cross-functional teams, and prepare design control documentation in line with FDA and ISO13485 requirements. Strong communication and problem-solving skills are essential.

Qualifications

• Bachelor’s degree in Engineering or a technical discipline
• 4+ years of related experience
• Knowledge of medical device regulations (ISO13485, FDA)
• Experience in process development for manufacturing medical devices
• Strong written and verbal communication
• Experience with FDA-regulated environment and GxP

Responsibilities

• Specify, design, verify and validate new manufacturing processes and equipment
• Troubleshoot process equipment and optimize processes
• Develop process/product specifications and validation protocols
• Lead cross-functional development teams
• Write and submit Engineering Change Orders
• Maintain effectiveness of the quality system
• Follow FDA design controls procedures
• Develop/implement new processes and equipment

Skills

Engineering principles

Design controls

Mechanical engineering

Chemical engineering

Communication skills

Statistical analysis

Design for manufacturing

Education

Bachelor’s degree in Engineering or technical field

Master’s degree

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 122,000 colleagues serve people in more than 160 countries.

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 Join us at Abbott Diabetes Care (ADC) in our mission to help individuals with diabetes lead active, fulfilling lives. We’re focused on helping people manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions.

Process Engineer III

Process Engineer III provides engineering support for new and existing equipment and processes used in T manufacturing operations. This role develops and implements equipment upgrades and modifications to reduce product costs and improve product quality, participates in and leads project teams requiring engineered solutions for new equipment, products, or processes, and implements, documents, and maintains controlled, repeatable production processes.

What You’ll Work On

• Specify, design, verify and validate new manufacturing processes and equipment, in accordance with applicable medical regulatory standards.
• Troubleshoots process equipment and perform process optimization.
• Develops process/product specifications, conduct pFMEAs, DOEs, validation protocols/reports and other associated documentation following design control requirements.
• Communicate effectively and participate on cross functional development teams.
• Conducts or participates in technical design reviews for process equipment and product design and requirements documents.
• Write and submit Engineering Change Orders, as required.
• Responsible for utilizing and maintaining the effectiveness of the quality system.
• Development and implementation of new processes, equipment, materials, verification and validation.
• Follow approved Design Control procedures for process development in accordance with FDA guidelines.

Required Qualifications

• Bachelor’s degree Engineering/Technical Discipline or an equivalent combination of education and work experience
• 4+ years of related experience
• Solid knowledge of general Engineering principles.
• Good knowledge of design controls and regulations for medical device development, (ISO134851, ISO13485, FDA).
• Strong technical experience in mechanical or chemical engineering with excellent written and verbal communication skills are essential.
• Strong understanding of processes and materials used in the development and manufacturing of medical devices, particularly diabetes strips.
• Experience in all of the following: performing engineering calculations and relating results to controlled tests, including statistical analysis, tolerance analysis working in a development environment with a disciplined process/product development process.
• Writing process/product requirements and design specifications.
• Working on a development team with an emphasis on minimizing time to market.
• Design for manufacturing low cost, high volume electronic products.
• Development of processes in an FDA regulated environment with full understanding of GxP, ISO and medical device regulations.
• Cross functional team environments is required.

Preferred Qualifications

• Master’s degree
• Experience in a mid-volume manufacturing environment, preferably within the medical device industry.

The base pay for this position is $90,000.00 – $180,000.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Engineering

DIVISION: ADC Diabetes Care

LOCATION: United States > Alameda : 2901 Harbor Bay Parkway

WORK SHIFT: Standard

TRAVEL: No

MEDICAL SURVEILLANCE: No

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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.

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.