Abbott Laboratories
Engineer II – Software Design Assurance
Abbott Laboratories, Pleasanton, California, United States, 94566
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. 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 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 Pleasanton, CA office in our Heart Failure division. In Abbott’s Heart Failure business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. What You’ll Work On Review traceability between software requirements and test cases. Support tracing of risks and ensure appropriate documentation is maintained. Review software development documentation including plans, protocols, and reports. Participate in meetings to discuss and review issues captured in problem resolution systems. Support risk evaluation activities such as FMEA and product risk analysis. Assist in technical reviews to ensure design deliverables are met. Support validation activities for non-product software as needed. Maintain compliance with US FDA regulations, other country regulatory requirements, company policies, and procedures. Collaborate with cross-functional teams, especially R&D. Support audits and quality system improvement activities. Additional responsibilities may be assigned as needed. Required Qualifications Master’s degree in engineering or Technical Field with 0 to 1 year of experience, or Bachelor’s degree in engineering or Technical Field with minimum 2 years of related work experience. Basic understanding of regulations, standards, and guidance affecting medical software development. Strong verbal and written communication skills. Preferred Qualifications Previous experience in quality engineering or use of quality tools/methodologies. Experience working in a cross-functional team environment. Knowledge of Software Development Lifecycle (SDLC) processes Knowledge of basic Risk Management concepts 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. The base pay for this position is $79,500.00 – $138,700.00. In specific locations, the pay range may vary from the range posted.
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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. 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 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 Pleasanton, CA office in our Heart Failure division. In Abbott’s Heart Failure business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. What You’ll Work On Review traceability between software requirements and test cases. Support tracing of risks and ensure appropriate documentation is maintained. Review software development documentation including plans, protocols, and reports. Participate in meetings to discuss and review issues captured in problem resolution systems. Support risk evaluation activities such as FMEA and product risk analysis. Assist in technical reviews to ensure design deliverables are met. Support validation activities for non-product software as needed. Maintain compliance with US FDA regulations, other country regulatory requirements, company policies, and procedures. Collaborate with cross-functional teams, especially R&D. Support audits and quality system improvement activities. Additional responsibilities may be assigned as needed. Required Qualifications Master’s degree in engineering or Technical Field with 0 to 1 year of experience, or Bachelor’s degree in engineering or Technical Field with minimum 2 years of related work experience. Basic understanding of regulations, standards, and guidance affecting medical software development. Strong verbal and written communication skills. Preferred Qualifications Previous experience in quality engineering or use of quality tools/methodologies. Experience working in a cross-functional team environment. Knowledge of Software Development Lifecycle (SDLC) processes Knowledge of basic Risk Management concepts 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. The base pay for this position is $79,500.00 – $138,700.00. In specific locations, the pay range may vary from the range posted.
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