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Abbott Senior Design Quality Engineer in St. Paul, Minnesota

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 103,000 colleagues serve people in more than 160 countries.

Position Summary:

We are recruiting for a Senior Design Quality Engineer to join our team in our St. Paul, MN location. In this role, you will lead incoming receiving inspections (scrap, nonconforming material, follow up with suppliers, inventory control), develop and implement product and quality specifications and quality plans, and perform the necessary risk analyses (FMEAs, MPI, LHRs, STMs) in conjunction with other product development team members.

Accountability: Understands business environment and relates extensive knowledge of internal and external technological activities to trends. Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. Participates in the development of other technical contributors by facilitating training and providing feedback and guidance. May lead a project team. Provides technical leadership to business units. Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees. Exercises judgment independently.

Planning/Organization: Plans and organizes project assignments of substantial variety and complexity. Initiates or maintains schedule for projects and project milestones. Establishes priorities of individual or project assignments.

Decision Making/Impact: Selects methods and techniques to lead a project to completion. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives.

Primary Responsibilities:

  • Provides quality assurance and quality engineering support to product development teams for drawings, material specifications, engineering reports and protocols, design verification and validation activities.

  • Supports, reviews and approves Document Change Orders.

  • Supports R&D product builds in the clean room for bench testing, animal lab, and first in human activities.

  • Develop, review, and approve rework instructions, in process inspections, and final product inspections.

  • Support clean room certification and validation activities.

  • Creates Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, by identifying & implementing more effective tools & materials, and by communicating new tools/materials to respective teams.

Required Qualifications:

  • Bachelor's Degree within an Engineering field or related discipline

  • 5+ years of related work experience in a Quality Engineer function and/or working in a quality system environment

  • Prior experience working with any or all of the following:

  • ISO 13485:2012 Medical Devices – Quality Management System

  • 21 CFR Part 820 FDA Quality System Regulations

  • ISO 14971 Medical Devices – Application of Risk Management

  • Good Manufacturing Practices And Good Documentation Practices

  • Previous experience working in a highly matrixed and geographically diverse business environment with the ability to leverage and/or engage others to accomplish projects.

  • Demonstrated experience working on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.

  • Proven experience exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business.

  • Excellent verbal and written communication skills, with ability to communicate to all levels of the organization

Preferred Qualifications:

  • Advanced degree in a technical field

  • Medical device experience, specifically working with valves and/or implantable devices

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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