Senior Development Quality Engineer

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:

Senior Development Quality Engineer

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.

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• 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 Team. Our products include prosthetic heart valves, occluder and devices for treatment of other structural heart defects.

As the Senior Development Quality Engineer, you’ll support sustainability of commercially released products. 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.

What You’ll Work On

• Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).

• Lead on-time completion of Quality deliverables and business initiatives. 

• Support the definition of objective, measurable, discrete, and verifiable customer requirements and product requirements.

• Lead Risk Management activities including analyzing field data to support Failure Mode Effects Analysis and Hazard 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 design changes on Commercial products.

• Support Supplier related changes for Commercial products.

• Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identifying, communicating, and resolving gaps.

• Support, review, and approve Document Change Order in a timely manner.

• Lead, coach, and mentor junior engineers.

• 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, Regulatory Affairs, Supplier Quality, Manufacturing Quality, Manufacturing Engineering and Process Development to ensure cross functional customer needs are met without creating barriers to development cost, time, and scope.

• Support regulatory audits as a Subject Matter Expert for Design Controls and other aspects of the quality system.

• 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 compliance.

• Own Corrective Action/Preventive Action (CAPA) investigations.

• Additional duties may be identified by functional management based on current project/business objectives.

• Complies with U.S. F