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 II

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 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 an Engineer II, you will be providing development and sustaining support as a part of a multidisciplinary product development team, overseeing projects throughout concept to launch in all phases of Design Production/Process Controls with a focus in the disposable catheter. You will be a key contributor to the design, development and testing activities for complex medical devices.

Who we want:

Critical thinkers: People who challenge status quo and work to find just the right solutions.

Collaborators: Partners who listen to ideas, share thoughts, and work together to move the business forward.

Problem Solvers: People who can take on complex problems and apply first principles and sound technical practices.

Communicators: People who can communicate project progress, data analysis and conclusions effectively across a broad set of stakeholders.

Responsible: People who own their deliverables and activities and see things through to completion. People who take personal accountability for end results.

What you’ll work on:

Be a core team member to implement complex development projects including quality improvement initiatives.

Cross-functional team member and driving towards compliant and efficient solutions to complex problems.

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

Technical analysis of requirements, specifications, and control strategy

Efficient and cost-effective execution of validation and verification

Alignment of design outputs to production and process controls

Proper verification techniques including inspection, demonstration, test, etc.

Support design and process characterization activities for development projects

Apply statistics to design/process and verification decisions.

Support design/process test and inspection method development, and lead method validation activities.

Lead root cause investigations, including corrective and preventive action activities, with the purpose of identifying the underlying issues and offering efficient long-term solutions.

Ensure DHF, DMR, DHR content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps.

Participate in internal and external inspections and inquiries from regulators such as FDA and ISO as it relates to design assurance.

Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements.

Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

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, and vendors.

Performs other related duties and responsibilities, on occasion, as assigned.

Required Qualifications:

Bachelor level degree in Engineering or Technical Field

Minimum of 3 years engineering experience with new product development

Minimum of 3 years quality engineering experience supporting disposable ablation catheter production

Minimum of 3 years experience owning NCMRs, CAPAs, Stop Ships, and HHEs

Working knowledge on design/process verification and design/process validation techniques.

Working knowledge of applied statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab.

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

Ability to collaborate on-site on a regular basis.

Ability to travel approximately 10%, including internationally.

Knowledge of FDA, IEC 60601, GMP, ISO 13485, and ISO 14971

Prior medical device experience preferred.

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.

The base pay for this position is $66,700.00 – $133,300.00. In specific locations, the pay range may vary from the range posted.