Senior Process Engineer III – Medical Device Manufacturing

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

Benefits offered by this job

Healthcare plan

Retirement plan

Tuition reimbursement

Job summary

Abbott Diabetes Care (ADC) in Alameda, CA is hiring a Process Engineer III to support on-site manufacturing equipment and processes. You will lead upgrades, support cost reduction and quality improvements, and guide project teams with regulated manufacturing practices.

The role requires a strong background in mechanical or chemical engineering, knowledge of ISO/FDA design controls, and experience in development environments focused on medical devices, including diabetes strips.

Qualifications

• Bachelor’s degree in engineering/technical discipline or equivalent.
• 4+ years of related experience in medical device engineering.
• Solid knowledge of general engineering principles.
• Knowledge of design controls and regulatory standards (ISO13485, FDA).
• Experience with mechanical or chemical engineering and strong communication.
• Experience with FDA-regulated environments and GxP.
• Cross-functional team collaboration.
• DFM, high-volume electronics development.

Responsibilities

• Specify, design, verify and validate new manufacturing processes and equipment per medical regulatory standards.
• Troubleshoot process equipment and optimize processes.
• Develop process/product specifications, perform pFMEAs, DOEs, validation protocols and reports.
• Communicate with cross-functional development teams.
• Conduct design reviews for process equipment and product design requirements.
• Submit Engineering Change Orders as required.
• Maintain effectiveness of the quality system.
• Develop and implement new processes, equipment, materials, verification and validation.
• Follow FDA Design Control procedures for process development.

Skills

Bachelor’s degree

4+ years experience

Engineering principles

Design controls

Regulations

Mechanical engineering

Chemical engineering

Communication skills

Medical devices materials

Statistical analysis

Tolerance analysis

Requirements specs

Time-to-market

DFM / high volume electronics

FDA regulations

Cross-functional teamwork

Education

Bachelor’s degree in Engineering/Technical Discipline

Master’s degree

Job description

Abbott Diabetes Care (ADC) in Alameda, CA is hiring a Process Engineer III to support on-site manufacturing equipment and processes. You will lead upgrades, support cost reduction and quality improvements, and guide project teams with regulated manufacturing practices.

The role requires a strong background in mechanical or chemical engineering, knowledge of ISO/FDA design controls, and experience in development environments focused on medical devices, including diabetes strips.