Manufacturing Process Engineer I – Medical Devices

abbott; Pleasanton (CA); On-site; USD 74,000 - 116,000; Full time

Benefits offered by this job

Medical coverage

Retirement plan

Tuition reimbursement

Free U education

Job summary

Abbott is seeking a process engineering professional for Pleasanton, CA to assist in developing new manufacturing processes and equipment for medical devices. You’ll work on process verification, validation, and optimization, joining cross-functional teams.

The role emphasizes adherence to FDA guidelines and Design Control procedures, with a strong focus on maintaining quality systems. A background in mechanical or chemical engineering and ≥3 years experience are required.

Qualifications

• Associates’ Degree in an Engineering / Technical Discipline (Mechanical, Chemical, Electrical or Physics preferred) or an equivalent combination of education and work experience.
• Minimum 3 years Technical or relevant experience.
• Knowledge of general engineering principals.
• Technical experience in mechanical or chemical engineering with excellent written and verbal communication skills.
• Knowledge of processes used in the development and manufacturing of medical devices, particularly diabetes strips.
• Experience in performing engineering calculations, controlled tests, statistical analyses.

Responsibilities

• Assist in designing or developing new manufacturing processes and equipment, and assist in process verification and validation.
• Assist in optimizing manufacturing processes.
• Conduct tests, collect and format data, and assist in analysis of engineering studies (DOEs).
• Assists in start up of new equipment and execution of validation protocols.
• Communicate effectively and participate on cross functional development teams.
• 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.
• Able to follow approved Design Control procedures for process development in accordance with FDA guidelines.

Skills

Engineering principles

Communication skills

Engineering calculations

Statistical analysis

Diabetes strips knowledge

Education

Associates’ Degree in Engineering/Technical Discipline

Bachelor’s degree

Job description

Abbott is seeking a process engineering professional for Pleasanton, CA to assist in developing new manufacturing processes and equipment for medical devices. You’ll work on process verification, validation, and optimization, joining cross-functional teams.

The role emphasizes adherence to FDA guidelines and Design Control procedures, with a strong focus on maintaining quality systems. A background in mechanical or chemical engineering and ≥3 years experience are required.