Senior Software Design Assurance Engineer

The Opportunity The Senior Software Design Assurance Engineer is responsible for supporting product development, executing and maintaining software quality engineering methodologies, and providing quality engineering support for software. The Senior Software Design Assurance Engineer position focuses primarily on software quality but also supports other aspects of product development based on experience. What You’ll Work On Provides technical and quality system guides related to establishing software requirements. Provides quality oversight for software verification and validation activities for new products in accordance with design planning procedures. This includes reviewing and approving software test case protocols and reports, reviewing software development plans, and reviewing other system and software documentation. Leads meetings to prioritize, review, and/or approve action plans for addressing issues captured in problem resolution systems during development. Leads risk evaluation and associated management activities related to software development, including risk assessments (e.g., FMEA), product risk analysis, and mitigation of software issues. Participates in technical and management reviews to ensure design plans, product design, and deliverables related to product software are met. Represents the quality engineering function for the review and approval of designated design outputs. Provides quality oversight for 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. Complies with US FDA regulations, other country regulatory requirements, company policies, and procedures. Maintains a strong, collaborative partnership with cross‑functional team members, especially with R&D. Works as an individual contributor and may provide guidance or oversee the work of other quality engineering team members. Develops and conducts training of company personnel for the divisional software development and validation program. Supports audits and leads quality system improvement activities. Additional responsibilities may be assigned as needed. Required Qualifications Bachelor’s degree in engineering or a technical field. Minimum of 5 years related work experience in quality or a related field. Knowledge of regulations, standards, and guidance affecting medical software and non‑medical device software development. Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization. Preferred Qualifications Advanced degree. Previous quality engineering experience and demonstrated use of quality tools and methodologies. Experience working in a broader enterprise or cross‑division business unit model. Benefits Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in the 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. Abbott is an Equal Opportunity Employer, committed to employee diversity. The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted. #J-18808-Ljbffr Abbott Laboratories