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Design Assurance / Development Quality Engineer (EII)

Company: Abbott Laboratories
Location: Saint Paul
Posted on: May 6, 2021

Job Description:

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 109,000 colleagues serve people in more than 160 countries.



JOB DESCRIPTION:

About Abbott

Structural Heart Business Mission: why we exist

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.

We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

WHAT YOULL DO

We are seeking an experienced engineer to join our Structural Heart Design Assurance / Development Quality team in either our Saint Paul, MN or Plymouth, MN location. The individual in this position 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 and lead completion of design control deliverables, such as design verification, design validation and risk management.

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

  • 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 Design Control Deliverables.
  • Create and ensure on-time execution ofQuality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects.
  • Accountable for Design Verification and Validation planning and execution, including active cross-functionalroot-cause analysis investigation and resolution activities.
  • Lead or support Risk Management activities, including analyzing field data to support new product development, supporting Failure Mode Effects Analysis, generation of risk management plans/reports, and completion of hazard analysis.
  • Support design test and inspection method development, and lead method validation activities.
  • Ensure Device History File (DHF) content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating and resolving gaps.
  • Support manufacturing process development and qualification for new product commercialization and product changes.
  • Support internal and external audit responses and on-time product re-certifications.
  • Support and ensure the establishment of objective, measurable, discrete, and verifiablecustomer and product requirements.
  • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications.
  • Support the development and review ofbiocompatibility and sterilization validations.
  • Supports R&D product builds for bench testing, animal lab, and first in human activities.
  • Complete Document Change Request Reviews in a timely and objective manner.
  • Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • 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.

    EDUCATION AND EXPERIENCE YOULL BRING

    Required

    • Bachelors degree within an Engineering field or related science-based discipline.
    • 2-5 years of related work experience.
    • Previous Quality engineering experience and demonstrated use of Quality tools/methodologies.
    • 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 in timely manner.
    • Strong organizational and follow-up skills, as well as attention to detail.
    • Ability to travel approximately 10%, including internationally.

      Preferred

      • Advanced degree in a technical field.
      • Medical device experience, specifically with valves and /or implantable devices.
      • Experience working in a broader enterprise/cross-division business unit model.
      • Prior experience working with any or all of the following:
        • ISO 13485 Medical Devices Quality Management System
        • 21 CFR Part 820 FDA Quality System Regulations
        • ISO 14971 Medical Devices Application of Risk Management
        • EUMDR
        • MDSAP
        • Good Manufacturing Practices And Good Documentation Practices

          WHAT WE OFFER

          At Abbott, you can have a good job that can grow into a great career. We offer:

          • Training and career development, with onboarding programs for new employees and tuition assistance
          • Financial security through competitive compensation, incentives and retirement plans
          • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
          • Paid time off
          • 401(k) retirement savings with a generous company match
          • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

            Learn more about our benefits that add real value to your life to help you live fully:

            Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an

            Equal Opportunity Employer, committed to employee diversity.

            Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.



            JOB FAMILY:Engineering



            DIVISION:SH Structural Heart



            LOCATION:United States > Minnesota> St. Paul > Woodridge : 177 East County Rd B



            ADDITIONAL LOCATIONS:



            WORK SHIFT:Standard



            TRAVEL:Not specified



            MEDICAL SURVEILLANCE:Not Applicable



            SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)



            Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.



            EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf



            EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Keywords: Abbott Laboratories, St. Paul , Design Assurance / Development Quality Engineer (EII), Other , Saint Paul, Minnesota

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