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Senior Development Quality Engineer

4 months ago

Saint Paul, Minnesota, United States Abbott Laboratories Full time

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

We are seeking an experienced Senior Development Quality Engineer to join our Structural Heart team at our St. Paul, MN location. The individual in this position will 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.


Primary Responsibilities:

  • 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 projects supporting quality and business initiatives.
  • Support the definition of objective, measurable, discrete, and verifiable customer requirements, external requirements, and product requirements.
  • Lead Risk Management activities including analyzing field data to update Risk Management File documents such as, Failure Modes and Effects Analysis (FMEA), Hazard Analysis, and Risk Management Plan/Report.
  • Support Test and Inspection Method development including Method Validation activities.
  • Accountable for Design Verification and Design Validation planning and execution, including cross-functional root-cause investigation and resolution activities.
  • Support manufacturing process development and qualification for design changes.
  • Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identifying, communicating, and resolving gaps.
  • Lead and support Corrective Action Preventive Actions (CAPAs) in a timely and objective manner.
  • Lead, coach, and mentor junior engineers.
  • Build strong collaborative partnerships with cross functional teams including Program Management, Research & Development, Regulatory, and Process Development to ensure cross functional customer needs are met without creating barriers to development cost, time, and scope.

Other Responsibilities:

  • Support internal and external audits as a Subject Matter Expert for Design Controls and other aspects of the quality system.
  • Support preparing Regulatory Submission documentation and responding to questions from Regulatory Agencies.
  • Write and revise SOPs, controlled forms, and related documents to ensure best practices and maintain compliance.
  • Additional duties may be identified by functional management based on current project/business objectives.
  • 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.
  • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Required Qualifications:

  • Bachelor's 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.
  • Be innovative, resourceful, and work with minimal direction. Have excellent organization, problem solving, communication, and team leadership skills. Work effectively with cross-functional teams.
  • 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.
  • Multitasks, prioritizes, and meets deadlines while delivering high-quality work
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel occasionally (