Senior Engineer, Process Development

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Irvine, CA location in the EP division.

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

As the Senior Engineer, Process Development, you'll have the chance to be an individual contributor with comprehensive knowledge in the area of Manufacturing Process Development. We are looking for someone who has the ability to execute highly complex or specialized projects and who can adapt precedent and may make significant departures from traditional approaches to develop solutions.

What You’ll Work On

• As the Specialist in the Manufacturing Process Development Sub-Function, considered as highly experienced and knowledgeable resource within the organization in designing and developing manufacturing processes for life sciences products, taking into consideration problems inherent in the transfer of technology from research to manufacturing.
• Such design and development may include new or revised processes.
• Develops procedures for the economical mass production in cooperation with pilot-plant and production departments.
• Conducts tests and measurements throughout stages of production to determine control over applicable variables.
• Services, troubleshoots and solves production process problems with processes or equipment already in operation.
• Requires understanding of compliance, pharmaceutical, pharmacological, biological, biochemical, medical, patent and commercial factors.
• May make recommendations concerning acquisition and use of new technological equipment and materials.

• Front line engineer supporting multiple product lines and operations team.

• Manage projects which include new production equipment validation, software validation, process characterization, process improvements, safety implementation, supporting new product introductions.

• Provide guidance to other engineers and technicians. 

• Support overall production line output, including and not limited to preventing/addressing line down concerns, production scrap dissection with root cause analysis and corrective actions, equipment related issues, material supply concerns, supporting NCMRs, CAPAs, and other business interruptions.

• Coordinate the design, procurement, build, debugging and qualification of tooling, machinery, and test equipment.

• Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts.

• Conduct Process FMEAs and Process Validations, PC, IQ, OQ, PQ, and Measurement System Bias.

• Create and Maintain manufacturing process, equipment, finished goods, and material documentation.

Required Qualifications

• Education Level: Bachelors Degree (± 16 years).
• Major/Field of Study: Engineering or an equivalent combination of education and work