Software Compliance Engineer
Not Disclosed•Full-TimeOn-site
location_on502, Central Avenue, West End, Alameda, Alameda County, California, 94501, United States
About Abbott
Abbott is a global healthcare leader helping people live more fully at all stages of life. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines. With 115,000 colleagues serving people in more than 160 countries, we are recognized as one of the most admired companies in the world by Fortune and a great place to work in dozens of countries.
About the Team
This role is based in our Alameda, CA location within the Diabetes Care division. We are focused on helping people with diabetes manage their health through life-changing products that provide accurate data to drive better-informed decisions. We are currently revolutionizing the way people monitor their glucose levels with new sensing technology.
About the Role
The Software Compliance Engineer serves as a lead member of the Software Quality Assurance (SWQA) team for Abbott Diabetes Care products. In this capacity, you will ensure that digital applications and firmware are developed, validated, and maintained in strict compliance with regulatory, corporate, and divisional requirements. You will monitor design controls governing the development, verification, validation, use, and maintenance of medical device software, while coordinating activities across engineering disciplines, departments, and contractors.
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. We offer career development within an international company, access to a Health Investment Plan (HIP) PPO medical plan, and an excellent retirement savings plan with high employer contributions. Additional benefits include tuition reimbursement, the Freedom 2 Save student debt program, and the FreeU education benefit for an affordable path to a bachelor's degree. We are 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.
Hiring Process
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. To learn more about our health and wellness benefits, visit abbottbenefits.com. Connect with us at abbott.com, on LinkedIn, or on Facebook.
Equal Opportunity
Abbott is an Equal Opportunity Employer, committed to employee diversity. We consider qualified applicants regardless of background, including Minorities, Women, Individuals with Disabilities, and Protected Veterans.
Work location
Work model: On-site
Similar Job Opportunities
Skills, education and keywords
Skills: Software Quality Assurance, Software Testing, Agile, Scrum, Fda QSR, Iso 13485, Iso 14971, 21 CFR Part 11, Design Control, Cybersecurity.
Education: Bachelor's degree or equivalent experience in scientific, technical, or engineering discipline.
Frequently asked questions about Software Compliance Engineer at Abbott
What does a Software Compliance Engineer at Abbott do?expand_more
A Software Compliance Engineer at Abbott is responsible for the following: Review change plans and provide guidance on software requirements and design descriptions; Review test plans and reports to ensure software changes are verified and adequately regressed; Participate in Agile software development processes including daily Scrum and Sprint ceremonies; and Serve as a Software Quality Assurance compliance subject matter expert for internal and external audits.
What are the requirements for this Software Compliance Engineer role?expand_more
Abbott is looking for candidates who meet the following requirements: Bachelor's degree or equivalent experience in scientific, technical, or engineering discipline; 2 to 5 years experience in Software Quality Assurance and/or Software Testing; Knowledge of FDA QSR, relevant ISO guidelines, 21 CFR Part 11, and Design Control requirements; 1 to 3 years project experience in software testing practices, methodologies including Agile; ASQ Certifications preferred; and Medical Device experience preferred.