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 114,000 colleagues serve people in more than 160 countries.

Design Assurance Engineer I

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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.

Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

As the Design Assurance Engineer I, you will represent Design Assurance on electrophysiology catheter and disposable sustaining engineering projects. This role is responsible for maintaining a strong collaborative partnership with cross-functional engineering teams to ensure that changes to existing devices are executed in accordance with product requirements, and that they meet their intended use delivering the safest experience possible to our patients. This role will review requirements, specifications, and technical design documents to provide timely feedback aimed at improving product quality, safety, reliability, and manufacturability to sustaining engineering teams.

What You’ll Work On

Execute on Holistic & Strategic Design Verification/Validation Strategies with emphasis on:

No issues escaping the change evaluation process

Efficient and cost effective

Ensure design controls from the patient to the supply chain are maintained during product or supplier changes

Maintain DHF, design input / design output, external requirements, and risk management documentation

Lead risk management meetings assessing the impact of product or supplier changes to risk profile

Lead design verification and validation activities including test planning and execution, and creation of protocols and reports

Interpret external standards and implement product requirements and testing to meet external standards

Ensure DHF content completion, integrity, and regulatory and standards compliance; collaboratively communicating and resolving gaps

Support design, test, inspection method development, and lead method validation activities

Participate in design failure root cause investigations including corrective and preventive action activities

Present to the manager level on significant matters

Serve as a back-room representative during internal and external inspections and inquiries from regulators such as FDA and ISO as it relates to design assurance

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

Required Qualifications

Bachelor level degree in an Engineering Discipline

0-2+ years’ experience

Ability to work both within a team, and independently, in a geographically diverse business environment

Ability to leverage and/or engage others to accomplish projects

Attention to Detail: Critical for ensuring compliance and quality

Collaboration: Ability to work effectively in cross-functional teams

Systemic Thinking: Understanding how individual decisions impact the overall project

Flexibility: Adaptability to changing project requirements and priorities

Communication: Strong verbal and written communication skills

Preferred Qualifications

Degree in Material Science, Mechanical, or Biomedical Engineering

Engineering experience and demonstrated use of Quality tools/methodologies

Knowledge of FDA, GMP, ISO 13485, and ISO 14971

Prior medical device experience

Strong technical writing skills

Experience with root cause identification and problem solving

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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 Twitter @AbbottNews.

The base pay for this position is $50,000.00 – $100,000.00. In specific locations, the pay range may vary from the range posted.