Development Quality Engineer I

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

• An excellent retirement savings plan with a high employer contribution

• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Woodridge location in St. Paul, MN in the Structural Heart Medical Device division. 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.

A development quality engineer assures 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.   

What You'll Work On

• Execute on-time completion of design control deliverables

• Design verification and validation test planning

• Design verification and validation test protocols, execution and reports

• Design input output trace matrix

• Design History File organization

• Customer, system, and product requirement review

• Regulatory responses and submissions

• Risk/hazard analysis and risk management plan/reports

• Design specification reviews

• Quality plans

• Design change plan/reports

• Investigate internal and external audit findings and write responses

• Corrective and preventive action resolution

• Complete document change requests

• Ability to work independently with minimal/no supervision

• Maintain high standards for content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating & resolving gaps

• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments

• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

• 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

• Perform other duties and responsibilities as assigned by functional management based on the current project/business objectives including up to 10% travel and regular predictable attendance

• This not a work from home position

Required Qualifications

• 0-2 years’ experience in R&D or Quality role

• Bachelor level degree in an Engineering Discipline or other Technical Field

• Solid communication and interpersonal skills

• Strong verbal communications and written communications with ability to effectively communicate at multiple levels in the Organization

• Advanced computer skills, including and report writing skills

• Ability to work within a team and as an individual contributor in a fast-paced, changing environment

• Multitasks, prioritizes and meets deadlines in timely manner

• Strong organizational and follow-up skills, as well as attention to detail

Preferred qualifications

• Degree in Mechanical, or Biomedical Engineering

• Previous Quality engineering experience and demonstrated use of Quality tools/methodologies, statistical/data analysis

• Prior medical device experience preferred

• Working knowledge of FDA 21 CFR Part 820, GMP, and ISO 13485

What We Offer

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

• A fast-paced work environment where your safety is our priority

• Production areas that are clean, well-lit and temperature-controlled

• 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

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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 X @AbbottNews.