Software Compliance Engineer

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 your 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 you dream of. 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were revolutionizing the way people monitor their glucose levels with our new sensing technology. The Software Compliance Engineer participates as a lead member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products that ensures digital applications and firmware produced by ADC is developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements. This person will monitor design controls that govern the development, verification, validation, use, and maintenance of medical device software. The Software Compliance Engineer will also coordinate activities with other engineering disciplines, departments, and contractors. What Youll Work On Reviews change plans for impact to project deliverables, and provides guidance to the document owners regarding changes to software requirements specifications, and software design descriptions for Abbotts suite of diabetes management software (cloud and mobile). Reviews test plans and test reports to ensure all software changes are verified, and software system is adequately regressed across all environments in accordance with design controls and Quality System Requirements. Monitors defect management process and provides guidance to Systems Engineering and V&V teams to ensure software bugs are logged, investigated, tested and dispositioned. Active participant in an Agile software development process, including daily Scrum and other recurring Sprint ceremonies. Completes software quality tasks in accordance with current Quality System Requirements. Works independently with objectives given by SWQA Manager. Can plan and coordinate own work according to higher-level project schedules. Assists in the development and maintenance of departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines (ISO 13485, ISO 14971), including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation, and maintenance of medical device software. Software Quality lead in various phases of the development lifecycle, as well as initiation of corrective and/or preventative action as it applies to software development activities. Maintains schedule and drive to meet project schedule as aligned with project(s) goals. Will also estimate, plan, schedule and review own and others work products and be accountable for the quality of those reviews and delivery on schedule. Considered SWQA compliance SME in support of external/internal audits. Required Qualifications Bachelors degree, or equivalent experience, in a scientific, technical, or engineering discipline. 2 to 5 years experience in Software Quality Assurance and/or Software Testing experience. Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of Design Control requirements. Must have 1 - 3 years project experience in software testing practices, methodologies including Agile and techniques, preferably in testing medical devices and mobile applications. Preferred Qualifications Must have excellent oral and written communication skills. ASQ Certifications a plus. Medical Device experience strongly preferred. Cybersecurity, medical mobile applications or cloud computing experience preferred. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://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 abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers. The base pay for this position is $90,000.00 $180,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: ADC Diabetes Care LOCATION: United States > Alameda : 2901 Harbor Bay Parkway ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time 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 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