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.

     

JOB DESCRIPTION:

Validation Engineer 

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 St. Paul, MN location in our Structural Heart Division. In Abbott’s Structural Heart (SH) business, our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

As the Validation Engineer, you'll be responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software utilized throughout business unit.

What You’ll Work On

• Develop and conduct training of company personnel for the divisional software development and validation program. 

• Work with  software owners in the completion of system/software requirements and other verification and validation processes. 

• Facilitate software validation protocols traceable to system/software requirements. 

• Implement solutions for controlling code and facilitate the use of Code Control and Software Event/Defect Tracking software systems. 

• Assist in the completion and maintenance of risk analysis, focused on software-related risks. 

• Design and implement various process improvement methodologies (i.e, Six Sigma and Lean Manufacturing). 

• Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving issues. 

• Assesses software for Part 11 applicability and other software validation deliverables. 

• 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. 

Required Qualifications

• Bachelors Degree in Engineering or Technical Field or an equivalent combination of education and work experience. 

• Minimum 2 years Software Quality Engineering or Quality Engineering experience 

• Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485. 

  Advanced computer skills, including statistical/data analysis and report writing. 

• Advanced Information Technology and data mining skills. 

  Ability to work in a highly matrixed and geographically-diverse business environment. 

• 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 projects. 

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

• Multitasks, prioritizes and meets deadlines in timely manner. 

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

• Ability to travel, including internationally, of up to 5%. 

Preferred Qualifications

• Prior medical device experience preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.
   

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 Twitter @AbbottNews.

     

The base pay for this position is

$61,300.00 – $122,700.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

SH Structural Heart

        

LOCATION:

United States > Minnesota > St. Paul : 1225 Old Highway 8 NW

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf