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

Structural Heart 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.

We are seeking a Staff Quality Engineer (E4) – Structural Heart to join our Structural Heart team at our St. Paul, 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 project planning activities including timelines and resource requirements, lead execution for completion of design control deliverables, as well as support sustainability of commercially released product.

WHAT YOU’LL DO

This position will be responsible for the day to day direction of the extended quality team and direct reports, as applicable, and requires exemplary motivation, communication, and organizational skills. The individual in this position will provide technical leadership to the business unit and participate in the development of other technical contributors by facilitating training and providing feedback and guidance. This individual will have a unique opportunity to make a mark on the organization as a leader by creating, developing, and managing an effective team environment, while working on state -of-the art products.

  • 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 new product development project deliverables

  • Support manufacturing process development and qualification for new product commercialization and product changes

  • Lead Risk Management activities, including analyzing field data to support new product development, and support Failure Mode Effects Analysis

  • Accountable for Process Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities

  • Support Test and Inspection Method development, and lead Method Validation activities

  • Identify and implement effective Process Control and monitoring of CTQ parameters and specifications

  • Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required

  • Supports, reviews, and approves Document Change Order and CAPA records

  • Supports product builds in the cleanroom for validation and commercial activities

  • Mentor cross functional teams as well as less-experienced staff and may provide work direction or supervise other technical employees

  • Support regulatory audits as Subject Matter Expert for Process Validation and other aspects of the quality system

  • Be innovative, resourceful, and work with minimal direction. Have excellent organization, problem solving, communication, and team leadership skills. Build strong, collaborative partnerships with cross-functional teams.

  • Additional duties may be identified by functional management based on current project/business objectives

  • 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

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

  • Bachelor’s degree within an Engineering field or related science-based discipline

  • Minimum of 9 years of related engineering experience with a minimum of 5 years of medical device experience with demonstrated use of Quality tools/methodologies

  • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner

  • 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

  • Ability to travel occasionally (<5%), including internationally

Preferred

  • Prior experience with nitinol, laser cutting, electropolishing, and/or implantable medical devices

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

  • 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: * www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

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 www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

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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