Process Engineer III

The Opportunity

Join us at Abbott Diabetes Care (ADC) in our mission to help individuals with diabetes lead active, fulfilling lives. We’re focused on helping people manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions.

Process Engineer III provides engineering support for new and existing equipment and processes used in T manufacturing operations. This role develops and implements equipment upgrades and modifications to reduce product costs and improve product quality, participates in and leads project teams requiring engineered solutions for new equipment, products, or processes, and implements, documents, and maintains controlled, repeatable production processes.

This is an onsite opportunity based out of Alameda, CA.

What You’ll Work On

• Specify, design, verify and validate new manufacturing processes and equipment, in accordance with applicable medical regulatory standards.
• Troubleshoots process equipment and perform process optimization.
• Develops process/product specifications, conduct pFMEAs, DOEs, validation protocols/reports and other associated documentation following design control requirements.
• Communicate effectively and participate on cross functional development teams.
• Conducts or participates in technical design reviews for process equipment and product design and requirements documents.
• Write and submit Engineering Change Orders, as required.
• Responsible for utilizing and maintaining the effectiveness of the quality system.
• Development and implementation of new processes, equipment, materials, verification and validation
• Follow approved Design Control procedures for process development in accordance with FDA guidelines.

Required Qualifications

• Bachelor’s degree Engineering/Technical Discipline or an equivalent combination of education and work experience
• 4+ years of related experience
• Solid knowledge of general Engineering principles.
• Good knowledge of design controls and regulations for medical device development, (ISO134851, ISO13485, FDA).
• Strong technical experience in mechanical or chemical engineering with excellent written and verbal communication skills are essential.
• Strong understanding of processes and materials used in the development and manufacturing of medical devices, particularly diabetes strips.
• Experience in all of the following: performing engineering calculations and relating results to controlled tests, including statistical analysis, tolerance analysis working in a development environment with a disciplined process/product development process.
• Writing process/product requirements and design specifications.
• Working on a development team with an emphasis on minimizing time to market.
• Design for manufacturing low cost, high volume electronic products.
• Development of processes in an FDA regulated environment with full understanding of GxP, ISO and medical device regulations.
• Cross functional team environments is required.

Preferred Qualifications

• Master’s degree
• Experience in a mid-volume manufacturing environment, preferably within the medical device industry.