Senior Software Design Assurance Engineer

Overview As a Senior Software Design Assurance Engineer, you ensure software quality throughout the development lifecycle. You will provide technical and quality guidance, oversee software verification/validation, and manage risk activities to secure compliant product solutions. You’ll collaborate with R&D and cross-functional teams to review designs, protocols, and documentation, and drive quality system improvements. This role offers impact across software products in medical and non-medical domains, with opportunities to shape quality practices and cybersecurity considerations. Join Abbott to contribute to health-focused innovation and global quality delivery. Compensation / BenefitsHealth Insurance (HIP PPO)Retirement savings planTuition reimbursementFreedom 2 Save student debt programFreeU education benefitCareer development opportunities ResponsibilitiesProvide technical and quality system guidance for establishing software requirementsOversee software verification and validation activities, including reviewing test case protocols, reports, and development plansLead meetings to prioritize and approve action plans for issues in problem resolution systemsLead risk evaluation and management activities (risk assessments, product risk analysis, mitigation of software issues)Participate in technical and management reviews to ensure design plans and deliverables are metRepresent QA in review/approval of designated design outputsProvide quality oversight for non-product software validation, assessing validation needs and supporting protocols and reportsCollaborate on cybersecurity assessments with cross-functional teamsEnsure compliance with US FDA regulations and other regulatory requirementsMaintain strong collaboration with cross-functional teams, especially R&D; may guide QE team membersDevelop and conduct training for divisional software development and validation programsSupport audits and lead quality system improvement initiativesPerform additional responsibilities as needed Key requirementsBachelor’s degree in engineering or a technical fieldMinimum of 5 years related work experience in Quality or a related fieldKnowledge of regulations, standards, and guidance affecting medical software and non-medical device software developmentStrong verbal and written communication abilitiesStrong communication (verbal and written)Collaboration and cross-functional teamworkLeadership in leading meetings and guiding othersSoftware quality engineeringUS FDA regulationsSoftware verification and validation