Design Assurance Engineer II

Job description

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 115,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

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 St. Paul, 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 II, you will be providing development support as a part of a multidisciplinary product development team, overseeing projects throughout concept to launch in all phases of Design Controls. You will be responsible for all quality deliverables throughout product development activities for complex medical-electrical systems.

We're looking for:

· 
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 do:

· 
Lead and implement complex development projects including quality improvement initiatives.

· 
Sets strategies for cross-functional teams and drives towards compliant and efficient solutions to complex problems.

· 
Execute on Holistic & Strategic Design Verification/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

· 
Lead Risk Management activities from product Concept through Commercialization

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

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

· 
Support and ensure internal & external audit responses and on-time product re-certifications

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

· 
Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications

· 
Develop and lead other team members

· 
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

Qualifications:

· 
Bachelor level degree in Engineering or Technical Field; advanced degree / Electrical Engineering preferred.

· 
2-5 years Quality engineering experience with new product development and demonstrated use of Quality tools/methodologies.

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

· 
People who can communicate project progress, data analysis and conclusions effectively.

· 
Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner

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

· 
Prior medical device experience preferred

· 
Design for Six Sigma and Critical to Quality training and experience preferred

· 
Experience working in a broader enterprise/cross-division business unit model preferred

· 
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, proactive manner

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

· 
Ability to travel approximately 10%, including internationally

· 
Ability to maintain regular and predictable attendance

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 and @AbbottGlobal.

     

The base pay for this position is
$57,300.00 – $114,700.00

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

     

JOB FAMILY:

Operations Quality

     

DIVISION:

EP Electrophysiology

        

LOCATION:

United States > Minnesota > St. Paul > Tech Center : One St Jude Medical Drive

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 10 % of the Time

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

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