Senior Process Engineer, Medical Devices & Manufacturing

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

Benefits offered by this job

Free medical coverage

High employer contribution retirement

Tuition reimbursement

Job summary

Abbott Diabetes Care in Alameda, CA is seeking a Process Engineer III to support new and existing equipment and processes used in manufacturing. You will lead upgrades, drive cost reductions, and improve product quality in a cross-functional setting.

This onsite role requires a BS in engineering, 4+ years of related experience, and strong knowledge of regulatory design controls and GMP. Diabetes strips experience is a plus; standard shift with no travel.

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 and medical device development standards (ISO13485, FDA).
• Experience in mechanical or chemical engineering with strong written/verbal communication.
• Experience with development/manufacturing of medical devices, especially diabetes strips.

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, conduct pFMEAs, DOEs, validation protocols and reports.
• Communicate effectively and participate on cross-functional development teams.
• Conduct technical design reviews for process equipment and product design documents.
• Submit Engineering Change Orders when required.
• Maintain effectiveness of the quality system and design controls per FDA guidelines.
• Develop and implement new processes and equipment.

Skills

Engineering calculations

Process optimization

Statistical analysis

Cross-functional teamwork

Communication skills

Design for manufacturing

Education

Bachelor’s degree in Engineering/Technical Discipline

Master’s degree

Job description

Abbott Diabetes Care in Alameda, CA is seeking a Process Engineer III to support new and existing equipment and processes used in manufacturing. You will lead upgrades, drive cost reductions, and improve product quality in a cross-functional setting.

This onsite role requires a BS in engineering, 4+ years of related experience, and strong knowledge of regulatory design controls and GMP. Diabetes strips experience is a plus; standard shift with no travel.