Design Assurance / Development Quality Engineer (EII)
Company: Abbott Laboratories
Location: Saint Paul
Posted on: May 6, 2021
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
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
- 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
- Support the development and review ofbiocompatibility and
- Supports R&D product builds for bench testing, animal lab,
and first in human activities.
- Complete Document Change Request Reviews in a timely and
- Participates in Corrective Action/Preventive Action (CAPA)
process including the investigation of failures or deviations, as
- Apply sound, systematic problem-solving methodologies in
identifying, prioritizing, communicating, and resolving quality
- 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,
EDUCATION AND EXPERIENCE YOULL BRING
- Bachelors degree within an Engineering field or related
- 2-5 years of related work experience.
- Previous Quality engineering experience and demonstrated use of
- Solid verbal, written, and interpersonal skills with ability to
effectively communicate at multiple levels in the
- Ability to work in a highly matrixed and geographically diverse
- 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
- Multitasks, prioritizes and meets deadlines in timely
- Strong organizational and follow-up skills, as well as
attention to detail.
- Ability to travel approximately 10%, including
- Advanced degree in a technical field.
- Medical device experience, specifically with valves and /or
- 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
- Good Manufacturing Practices And Good Documentation
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
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
DIVISION:SH Structural Heart
LOCATION:United States > Minnesota> St. Paul > Woodridge :
177 East County Rd B
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
EEO is the Law link - English:
EEO is the Law link - Espanol:
Keywords: Abbott Laboratories, St. Paul , Design Assurance / Development Quality Engineer (EII), Other , Saint Paul, Minnesota
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