Development Quality 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 114,000 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 Plymouth, MN location in the Structural Heart division. 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. As the Development Quality Engineer II, you’ll have the chance to assure new or modified products conform to requirements and establish compliance with the quality system. This position is 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. This position will support new product development projects and lead completion of design control deliverables, such as design verification, design validation and risk management. Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to act and accomplish goals. What You’ll Work On Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Design Quality function as a Core Team Member) 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 and execution, including active cross-functional root-cause analysis investigation and resolution activities Lead or support Risk Management activities, including analyzing field data to support new product development, supporting Failure Mode Effects Analysis, generation of risk management plans/reports, and completion of hazard analysis Support design test and inspection method development, and lead test method validation activities Ensure Device History File (DHF) content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating, and resolving gaps Support manufacturing process development and qualification for new product commercialization and product changes Support internal and 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 Support the development and review of biocompatibility and sterilization validations Supports R&D product builds for bench testing, animal lab, and first in human activities. Complete Document Change Request Reviews in a timely and objective manner Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues 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 Other Duties: 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 Required Qualifications: Bachelor’s degree within an Engineering field or related science-based discipline 2-5 years of related work 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 up to 10%. This is not a work from home position Preferred Qualifications: Advanced degree in a technical field Medical device experience, specifically with heart valves and /or implantable devices Experience working in a broader enterprise/cross-division business unit model Prior experience working with any or all of the following: ISO 13485 Medical Devices – Quality Management System 21 CFR Part 820 FDA Quality System Regulations ISO 14971 Medical Devices – Application of Risk Management EUMDR MDSAP Good Manufacturing Practices And Good Documentation Practices 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: SH Structural Heart LOCATION: United States > Minnesota > Plymouth : 5050 Nathan Lane N ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: No MEDICAL SURVEILLANCE: No 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 135 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 160 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. Follow Us: Facebook LinkedIn YouTube Twitter

Salary : $56,700 - $113,300