Design Assurance Engineer II
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.
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 [Register to View] student debt program and [Register to View] 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.
As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
This position works out of our Minnetonka, MN location in the Cardiac Rhythm Management division.
We are seeking a high caliber, motivated, self-driven Design Assurance Quality Engineer II who will assist to assure new or modified products conform to requirements and establish compliance with the quality system. They are 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 and support on-time completion of Design Control Deliverables
Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
Accountable for Design Verification and Validation planning & execution, statistical analysis, including active cross-functional root-cause analysis investigation & resolution activities
Lead or support Risk Management activities from product Concept through Commercialization
Support design test and inspection method development, and lead method validation activities
Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Support manufacturing process development & qualification for new product commercialization and product changes
Support internal & external audit responses
Support product re-certifications
Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements
Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications
Support execution of biocompatibility and sterilization qualifications
Complete Document Change Request Reviews in a timely and objective manner
Additional duties may be identified by functional management based on the current project/business objectives.
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.
EDUCATION AND EXPERIENCE YOU’LL BRING
Bachelors Degree (± 16 years) Engineering or Technical Field OR an equivalent combination of education and work experience
Masters Degree (± 18 years) Preferred
2 years experience
Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
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.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel approximately 10%, including internationally(if required)
Medical device experience preferred, but not required
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 (Manufacturing roles only)
Production areas that are clean, well-lit and temperature-controlled (Manufacturing roles only)
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
Learn more about our benefits that add real value to your life to help you live fully: [Register to View] , on Facebook at [Register to View] target="_blank">[Register to View] and on Twitter @AbbottNews and [Register to View]