Staff Engineer, Software Design Assurance (Medical ...

The OpportunityThis position works onsite out of our Pleasanton, CA or Burlington, MA location in the Abbott Heart Failure Division Global Design Quality Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.We are seeking an experienced Staff Engineer, Software Design Quality to ensure our medical devices are developed in accordance with Abbott’s design control requirements and state of the art standards. The Staff Engineer, Software Design Quality will serve as a technical representative providing quality oversight for Software Development projects. The Staff Engineer, Software Design Quality is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software.What You’ll Work OnAs part of the Global Design Quality Department, provide oversight of R&D design control deliverables for development of medical product software (Cloud Patient Care Networks, mobile applications and embedded software), non-medical software, and non-product softwareSupport software verification and validation activities for new products and software changes in accordance with plans. Review and approve of requirements, software test case protocols/reports, software development plans, and other system and software documentation.Participate in meetings to evaluate, prioritize, and develop action plans for addressing software defects/bugs captured in the problem resolution systemsPerform risk assessments and associated management activities related to software development including FMEA, product risk analysis, and mitigation of software issues.Participate in technical and management reviews to ensure design plans, product designs, and deliverables related to product software are met. Represent the Global Design Quality Department for final review and approval of project deliverablesSupport non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required.May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team.Work as an individual contributor and provide guidance or oversee work of other Software Quality team members.Support audits and lead quality system improvement ply with U.S. Food and Drug Administration (FDA) regulations, EUMDR, and other regulatory requirements and Abbott policies, processes, and procedures.Required QualificationsBachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline.Minimum 8 years of Software Development and Design Quality Engineering experience or an equivalent combination of education and experience.Knowledge of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (e.g., 62304), EU Medical Device Regulations and MDSAPExperience with medical device software development lifecycle for Cloud-based networks and/or mobile applications.Preferred QualificationsExperience using requirements management tools (e.g., DOORS) and using problem reporting systems (e.g., JIRA).Hands-on experience with FMEA/risk management.Experience developing or maintaining design controls for software development.Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: 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 , on Facebook, and on Twitter @AbbottNews.Salary: The base pay for this position is $97,300.00 – $194,700.00. In specific locations, the pay range may vary from the range posted.JOB FAMILY: Operations QualityDIVISION: HF Heart FailureLOCATION: United States > Massachusetts > Burlington : 168 Middlesex TurnpikeADDITIONAL LOCATIONS: United States > Pleasanton : 6101 Stoneridge DrWORK SHIFT: StandardTRAVEL: Yes, 10 % of the TimeMEDICAL SURVEILLANCE: NoSIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. #J-18808-Ljbffr

Created: 2025-09-28