Senior Process Engineer – Medical Devices

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 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.