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.

　　Senior R&D Engineer

　　Plymouth, MN

　　Position Summary:

　　As a Senior R&D Engineer , you will be part of our Transcatheter Aortic Valve Implantation (TAVI) research and development team focused on delivering the future in heart valve therapy. This role will provide technical leadership 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 expert while working on state-of-the art products.

　　Primary Responsibilities:

　　Lead and participate 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

　　Lead Design Verification and shelf life planning and execution, including cross-functional root-cause analysis investigation and resolution activities

　　Drive 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

　　Mentor less-experienced staff and cross functional teams, may provide work direction or supervise other technical employees

　　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 5 years of related engineering experience with a minimum of 3 years of medical device experience and demonstrated solid 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 (<5%)

　　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

　　Abbott Structural Heart

　　From transcatheter and surgical valves to structural interventions, the Abbott Structural Heart portfolio spans a wide range of life-changing technologies. Abbott is at the forefront of transforming structural heart therapies, leading the development of more advanced solutions for patient care.

　　As a passionate, committed, and innovative team, we strive 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. We aim to lead the markets we serve by requiring our products provide customers an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

　　The base pay for this position is $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.

　　An Equal Opportunity Employer

　　Abbot welcomes and encourages diversity in our workforce.

　　We provide reasonable accommodation to qualified individuals with disabilities.

　　To request accommodation, please call 224-667-4913 or email [email protected]