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Senior Development Quality Engineer

3 months ago

St Paul, United States Abbott Laboratories Full time

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.

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. Youâll 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 bachelorâs 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 Senior Development Quality Engineer 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.

What Youâll 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 project supported 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.
  • 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 and CAPA records in a timely and objective manner.
  • Support product builds in the cleanroom for development and commercial activities.
  • 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, and Process Development to ensure cross functional customer needs are met without creating barriers to development cost, time, and scope.

Required Qualifications

  • Bachelorâs degree within an Engineering field or a closely related discipline.
  • 5-8+ years of medical device engineering experience and demonstrated use of Quality tools/methodologies.
  • Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.
  • Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel occasionally (