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.
- The base pay for this position is
- $90,000.00 – $180,000.00
- In specific locations, the pay range may vary from the range posted.
JOB FAMILY
Engineering
DIVISION
ADC Diabetes Care
LOCATION
United States > Alameda : 2901 Harbor Bay Parkway
ADDITIONAL LOCATIONS
WORK SHIFT
Standard
TRAVEL
No
MEDICAL SURVEILLANCE
No
SIGNIFICANT WORK ACTIVITIES
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
