Staff Engineer, Design Assurance- Software

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

• Own software design assurance for new products and significant changes across the full development life cycle
• Plan and lead design control activities, ensuring complete, auditable traceability from user needs through requirements, architecture, implementation, verification, validation, and release
• Provide oversight of R&D design control deliverables for development of medical product software
• Define and approve verification and validation strategies proportionate to software safety classification per IEC 62304
• Review and approve software development plans, requirements, test protocols and reports, cybersecurity tests, and associated documentation for embedded, mobile, and cloud components
• Support software verification and validation activities for new products and software changes in accordance with plans
• Participate in meetings to evaluate, prioritize, and develop action plans for addressing software defects/bugs captured in the problem resolution systems
• Lead risk management for software and system hazards in accordance with ISO 14971
• Provide quality oversight for defect and change control processes
• Mentor engineers in design controls, software life-cycle best practices, cybersecurity by design, and risk management
• Prepare for and participate in internal and external audits and regulatory inspections

• Bachelor’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 MDSAP
• Experience with medical device software development lifecycle for Cloud-based networks and/or mobile applications
• Demonstrated leadership as a quality core-team member on complex programs involving mobile and cloud components

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
• Excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit
• A company recognized as a great place to work in dozens of countries around the world
• 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 a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.