Senior Process Engineer – Medical Device Manufacturing

Abbott; United States; On-site; USD 90,000 - 140,000; Full time

Job summary

Abbott Diabetes Care (ADC) in Alameda, CA is seeking a qualified Process Engineer III to support manufacturing equipment and processes. You will lead upgrades and modifications to reduce costs and improve quality, and guide cross-functional teams in implementing engineered solutions for new equipment, products, or processes.

The role requires a Bachelor's in Engineering and 4+ years of related experience, with strong knowledge of design controls, ISO and FDA regulations, and experience in

Qualifications

• Bachelor's degree in Engineering/Technical Discipline or an equivalent combination of education and work experience.
• 4+ years of related experience.
• Solid knowledge of general Engineering principles.
• Strong knowledge of design controls and regulations for medical device development (ISO134851, ISO13485, FDA).

Responsibilities

• Specify, design, verify and validate new manufacturing processes and equipment, following medical regulatory standards.
• Troubleshoot process equipment and perform process optimization.
• Develop process/product specifications, conduct pFMEAs, DOEs, validation protocols/reports and related documentation.
• Communicate effectively and participate on cross functional development teams.
• Conduct technical design reviews for process equipment and product design.
• Write and submit Engineering Change Orders as required.
• Maintain effectiveness of the quality system.
• Develop and implement new processes, equipment and materials validation.
• Follow FDA-aligned Design Control procedures for process development.

Skills

Process engineering

Manufacturing processes

Statistical analysis

Design controls

Education

Bachelor's degree in Engineering/Technical Discipline

Job description

Abbott Diabetes Care (ADC) in Alameda, CA is seeking a qualified Process Engineer III to support manufacturing equipment and processes. You will lead upgrades and modifications to reduce costs and improve quality, and guide cross-functional teams in implementing engineered solutions for new equipment, products, or processes.

The role requires a Bachelor's in Engineering and 4+ years of related experience, with strong knowledge of design controls, ISO and FDA regulations, and experience in