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R&D Engineer - Saint Paul, United States - Abbott Laboratories
![Abbott Laboratories background](https://contents.bebee.com/companies/us/abbott-laboratories/background-lxVCj.png)
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 114,000 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
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 OpportunityThis position works out of our Woodridge location in the SH division.
Structural Heart Business Mission:
why we exist
Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.
Transcatheter Aortic Valve Implantation (TAVI)
research and development team focused on delivering the future in heart valve therapy.
This role will provide technical support to the project teams and participate in the development of other technical contributors by mentoring and providing feedback.
This individual will have a unique opportunity to make a mark on the organization as a design controls and technical contributor while working on state-of-the art products.
What You'll Work OnParticipate in new product development process and ensure on-time completion of design controls deliverables including design verification, test method validation, design input output trace matrix, and other applicable business initiatives.
Participate in Design Verification and shelf life planning and execution, including cross-functional root-cause analysis investigation and resolution activitiesDrive best practices for design test and inspection method development and lead method validation activities.
Support and ensure the definition of objective, measurable, discrete, and verifiable customer requirements, external requirements, and product requirements.
Participate in Risk Management activities from product Concept through Commercialization, including Failure Mode Effects Analysis and requirement flow down.
Support other activities including regulatory submissions, internal & external audit responses as well as product re-certifications, corrective and preventive action (CAPA) resolution as Subject Matter Expert for Design Controls.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Be innovative, resourceful, and work with minimal direction. Have excellent organization, problem solving, communication, and team leadership skills.
Build strong collaborative partnerships with cross functional teams including Program Management, Quality, and Process Development to ensure cross functional customer needs are met without creating barriers to development cost, time, and scope.
Support Divisional initiatives as identified by functional management or divisional management as needed.Required Qualifications
Bachelor's degree within an Engineering field or related science-based discipline
Minimum of 2 years of related medical device experience and demonstrated strong understanding of Design Controls
Advanced computer skills, including statistical/data analysis and report writing skills
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Multitasks, prioritizes, and meets deadlines in timely manner.
Detailed knowledge of
21 CFR Part 820 , ISO 13485,
EUMDR, MDSAP,
ISO 14971, and
other applicable device-related standards
Demonstrated experience working on complex problems where analysis of situations or data requires an in-depth evaluation of various factors
Excellent verbal and written communication skills, with ability to communicate to all levels of the organization
Ability to travel occasionally (
Preferred Qualifications
Experience in the use/deployment of a requirements management environment, such as DOORS, Jama or Cognition Cockpit
Experience testing medical devices
Previous experience working in a highly matrixed and geographically diverse business environment with the ability to leverage and/or engage others to accomplish projects
Apply Now
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
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and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $57,300.00 – $114, In specific locations, the pay range may vary from the range posted.