Manufacturing Process Engineer II

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:

Manufacturing Process Engineer II

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 Westfield, Indiana location in the Structural Heart division. Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

This role is responsible for all manufacturing equipment and equipment quality/cost savings initiatives, improving efficiency through material and process improvement, reducing material processing costs, and participating in new product design.

What You’ll Work On

• Develops processes based on product specifications and in consideration to process and test method capabilities
• Evaluates process and design alternatives based on Design for Manufacturability (DFM) principles.
• Uses problem solving and statistical tools and make sound design recommendations.
• Manages program compliance with Quality requirements (i.e. Design Control, Process validation etc.).
• Can identify work environment issues (i.e. OSHA regulations, etc.).
• Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Conducts tests, collects and formats data, and assists in analysis of engineering studies (DOEs).
• Assists in start up of new equipment and execution of validation protocols.
• Participates in technical design reviews for process equipment and product design and requirements documents.
• Responsible for utilizing and maintaining the effectiveness of the quality system, including supporting Quality Incidents and CAPA investigations and actions.
• Analyzes raw material specifications to ensure appropriate features and limits are in place to support company manufacturing process.
• Evaluates company initiated raw material changes and coordinates appropriate testing and validation as required.
• Works to reduce costs in all areas of manufacturing by analyzing current equipment for process suitability and provides detailed plans for improvement.
• Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to insure compliant, efficient, and safe processes.
• Conducts preventative maintenance audits and compliance with SOPs, ISO, FDA and cGMP requirements.
• Researches engineering solutions to a diverse set of challenges in production and development.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

General Competencies:

• Multitasking: Demonstrates the ability to handle multiple tasks or responsibilities simultaneously by efficiently managing time, prioritizing tas