Principal Quality Engineer

Employer
Abbott Laboratories
Location
Minneapolis, MN
Posted
Sep 12, 2021
Closes
Sep 15, 2021
Ref
2445317525
Organization Type
Corporate
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 Business Mission: why we exist

From transcatheter and surgical valves to structural interventions, the Abbott Structural Heart portfolio spans a wide range of life-changing technologies. Abbott is at the forefront of transforming structural heart therapies, leading the development of more advanced solutions for patient care.

As a passionate, committed, and innovative team, we strive 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 our products provide customers 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 YOU'LL DO

We are seeking an experienced Staff (E4 equivalent) Design Assurance/Development Quality Engineer to join our SH team in our Plymouth, MN location, with support to 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 and third party providers, 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, and lead execution for completion of design control deliverables. This position will also lead the effort to update or create quality system procedures in support of new devices and working with third party providers for design, development and manufacturing of product.

This position may 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. Provides technical leadership to the business unit and participates in the development of other technical contributors by facilitating training, updating quality system procedures 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 aspects of the quality system, while working on state -of-the art products.

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.
  • Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities.
  • Lead Risk Management activities, including analyzing field data to support new product development, and supporting Failure Mode Effects Analysis.
  • Support design test and inspection method development, and lead method validation activities.
  • Support and ensure internal & external audit responses and on-time product re-certifications.
  • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements.
  • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications.
  • Supports, reviews and approves Document Change Order and CAPA records.
  • Supports R&D product builds in the cleanroom for bench testing, animal lab, and first in human activities.
  • Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating & resolving gaps.
  • Identify and drive opportunities to improve the quality system as it relates to design control deliverables.
  • Act as a mentor to 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 Design Controls and other aspects of the quality system.
  • Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required.
  • Writes and revises SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations.
  • Build strong collaborative partnerships with Program Management and Research & Development to ensure cross functional customer needs are met without creating barriers to development cost, time and scope.

EDUCATION AND EXPERIENCE YOU'LL BRING

Required
  • Bachelor's Degree within an Engineering field or related science-based discipline
  • 9+ years of related work experience in a Quality Engineer function and/or working in a quality system environment
  • Previous experience working in a highly matrixed and geographically diverse business environment with the ability to leverage and/or engage others to accomplish projects.
  • 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
  • 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

Preferred
  • Advanced degree in a technical field
  • Medical device experience, specifically working with valves and/or implantable devices
  • Experience in authoring regulatory responses and submissions

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

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.

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