Medical Device Manufacturing Process Engineer

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

Job summary

Abbott Laboratories in Pleasanton, CA, within the Heart Failure Division, is seeking a qualified engineer to assist in developing manufacturing processes and equipment for medical devices. The role focuses on process engineering problems, executing experiments, and building internal relationships to support production.

Key duties include designing and optimizing processes, conducting tests, doing DOEs, validating equipment startups, and ensuring quality system effectiveness in line with FDA

Qualifications

• 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 startup 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 knowledge

Communication skills

Education

Associate degree in engineering / Technical Discipline

Job description

Abbott Laboratories in Pleasanton, CA, within the Heart Failure Division, is seeking a qualified engineer to assist in developing manufacturing processes and equipment for medical devices. The role focuses on process engineering problems, executing experiments, and building internal relationships to support production.

Key duties include designing and optimizing processes, conducting tests, doing DOEs, validating equipment startups, and ensuring quality system effectiveness in line with FDA