Senior Engineer Development Quality

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. 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. Youll also have access to: Career development with an international company where you can grow the career of which you dream. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. 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 bachelors 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. MAIN PURPOSE OF THE ROLE The Senior Engineer, Development Quality assures new or modified products conform to quality standards and establishes compliance with the quality system. 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 is an ONSITE role based out of Minnetonka. MN. MAIN 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 Lead 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/lead and ensure internal & external audit responses Support/lead 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. Support/lead 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. 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 al levels of employees, customers, contractors, and vendors. QUALIFICATIONS Education Bachelors Degree (± 16 years) preferably in science, engineering or a closely related discipline (OR) an equivalent combination of education and work experience Masters Degree (± 18 years) preferred Experience/Background Minimum 5 years of relevant experience, such as Quality, Compliance, Engineering, within a regulated environment, such as medical device, diagnostics or pharmaceutical industries, to develop the competence required to meet the skills and responsibilities of the position. Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices. Previous experience with regulatory body. Knowledge of software regulations and compliance (21 CFR Part 11); - Knowledge of ISO 13485. Knowledge of quality management techniques and the application and principles of quality engineering. Strong knowledge and application of concepts, practices and procedures. Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors. Understanding of statistics. Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior. Ability to work independently and in groups; ability to work cross-functionally. Demonstrated initiative and problem-solving skills and critical-thinking skills. Ability and aptitude to use various types of databases and other computer software. Ability to prioritize. Strong organizational and project management skills. Ability or aptitude to lead without direct authority. Apply Now 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 $78,000.00 $156,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: CRM Cardiac Rhythm Management LOCATION: United States > Minnesota > Minnetonka : 14900 Minnetonka Industrial Road ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: Not Applicable 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 its 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 lifes 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