Abbott Senior Development Quality Engineer in Minneapolis, Minnesota
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
A design assurance engineer assures 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.
Duties and Responsibilities:
Lead on-time completion of Design Control Deliverables
Create and ensure 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, including active cross-functional root-cause analysis investigation & resolution activities
Lead 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 and ensure internal & external audit responses
Support and ensure 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
Accountable for development, execution and analysis of biocompatibility and sterilization qualifications
Complete Document Change Request Reviews in a timely and objective manner Develop and lead other team members.
Perform other duties and responsibilities as assigned by management.
Additional duties may be identified by functional management based on the current project/business objectives.
Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Bachelor level degree in Engineering or Technical Field
5-8+ 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.
Prior medical device experience preferred
Experience working in a broader enterprise/cross-division business unit model
Working understanding of FDA, GMP, and ISO 13485
Working understanding of the following standards 60601, 62304, &/or 14971
ASJM Abbott St. Jude Medical
United States of America > Plymouth 5050 Nathan Lane > S4509 : 5050 Nathan Lane N.
United States of America > St Paul (Woodridge) > S4515 : 177 East County Rd B
Yes, 10 % of the Time
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
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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