Lead Development Quality Engineer

4 weeks 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 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.
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
  • 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 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The position of Lead Development Quality Engineer is within our Structural Heart team at our St. Paul, MN location.

With our Structural Heart division, the 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 ensure that 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 the sustainability of commercially released products. This position may also support manufacturing processes to meet daily production schedules while enhancing productivity and product quality.

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 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 identify, communicate, and resolve 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 and implement technical team strategy and roadmap.
  • Assist in the development of direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate, and conducting formal written and verbal performance reviews.
  • Be innovative, resourceful, and work with minimal direction. Have excellent prioritization, 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 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.
  • Participate in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required.
  • 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.
  • 6-7+ 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 the ability to effectively communicate at multiple levels in the organizations.
  • Demonstrated ability to guide junior team members.
  • 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 promptly.
  • Ability to travel occasionally (

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