Development Quality 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:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our St. Paul, MN location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

The individual in this position will assure new or modified products conform to requirements and establish compliance with the quality system.  This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.  This position will support new product development projects as well as support sustainability of commercially released product. This position may also support manufacturing processes to meet daily production schedules while enhancing productivity and product quality.

Primary Responsibilities:

• Lead on-time completion of project supported Development Quality deliverables and business initiatives. 
• Support the definition of objective, measurable, discrete, and verifiable customer requirements, external requirements, and product requirements.
• Lead Risk Management activities from product Concept through Commercialization, including analyzing field data to support new product development, and support Failure Mode Effects Analysis.
• Support Test and Inspection Method development including Method Validation activities.
• Support Design Verification and Design Validation planning and execution, including cross-functional root-cause analysis investigation and resolution activities.
• Support manufacturing process development and qualification for new product commercialization and product changes.
• Accountable for Process Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities.
• Identify and implement effective Process Control and monitoring of CTQ parameters and specifications.
• Support, review, and approve Document Change Order and CAPA records in a timely and objective manner.
• Support product builds in the cleanroom for development and commercial activities.
• Be innovative, resourceful, and work with minimal direction. Have excellent organization, problem solving, communication, and team leadership skills. Work effectively with cross-functional teams.

• Build strong collaborative partnerships with cross functional teams including Program Management, Research & Development, and Process Development to ensure cross functional customer needs are met without creating barriers to development cost, time, and scope.

Other Responsibilities:

• Support and ensure internal & external audit responses and on-time product re-certifications.
• Writes and revises SOPs, controlled forms, and related documents to ensure best practices and maintain compl