15 days old

Design Assurance Engineer II

Abbott
St Paul, MN 55102

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.

Our Design Assurance Engineer II assures new or modified products conform to requirements and establish compliance with the quality system.  They are 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.

Main responsibilities:

  • Execute and support on-time completion of Design Control Deliverables
  • Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
  • Accountable for Design Verification and Validation planning & execution, statistical analysis, including active cross-functional root-cause analysis investigation & resolution activities
  • Lead or support Risk Management activities from product Concept through Commercialization
  • Support design test and inspection method development, and lead method validation activities
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Support manufacturing process development & qualification for new product commercialization and product changes
  • Support internal & external audit responses
  • Support product re-certifications
  • Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements
  • Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Support execution of biocompatibility and sterilization qualifications
  • Complete Document Change Request Reviews in a timely and objective manner
  • Additional duties may be identified by functional management based on the current project/business objectives.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • 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.
  • Performs other related duties and responsibilities, on occasion, as assigned.

    Required Qualifications:

    • Bachelor level degree in Engineering or Technical Field
    • 2-5 years 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.
    • Ability to maintain regular and predictable attendance.

      Preferred Qualifications:

      • Prior medical device experience preferred
      • Experience working in a broader enterprise/cross-division business unit model
      • ASQ Certified Quality Engineer / Six Sigma Green Belt Certification
      • Working understanding of FDA, GMP, and ISO 13485
      • Working understanding of the following standards 60601, 62304, &/or 14971Division: EPHF Electrophysiology & Heart Failure
        Travel: Yes, 15 % of the Time
        Medical Surveillance: No
        Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Categories

Posted: 2020-03-23 Expires: 2020-04-22

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Design Assurance Engineer II

Abbott
St Paul, MN 55102

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