**
Abbott is seeking a Senior Software Development Quality Engineer for its Neuromodulation division in Plano, TX. The role requires extensive experience in software quality within regulated industries, specifically focused on ensuring compliance with medical device standards.
**
Job Summary
Serve as the primary quality representative on cross-functional development teams for software-enabled implantable medical devices, ensuring compliance with design control requirements and patient safety objectives.
Provide quality engineering oversight for AI/ML-enabled software features, evaluating risk controls and ensuring traceability between hazards, requirements, and mitigation strategies.
Abbott offers a comprehensive benefits package including medical coverage, retirement savings plan, tuition reimbursement, and is recognized globally as a great place to work.
Matching Summary
Match Score: 75
**
Abbott is seeking a Senior Software Development Quality Engineer for its Neuromodulation division in Plano, TX. The role requires extensive experience in software quality within regulated industries, specifically focused on ensuring compliance with medical device standards.
**
Salary
$86,700.00 – $173,300.00
Skills & Requirements
Must-have
Software Development Quality Engineering
Medical Device Regulations
IEC 62304
ISO 14971
FDA 21 CFR Part 820
Design Control Requirements
Nice-to-have
AI/ML medical device experience
Cybersecurity requirements
Continuous improvement mindset
Cross-functional collaboration
Key Requirements
Bachelor's degree in Computer Science/Engineering, Biomedical Engineering, Electrical Engineering, or related technical discipline
8+ years of software quality or design quality experience in a regulated industry
Experience with medical device regulatory frameworks (IEC 62304, ISO 14971, ISO 13485, FDA 21 CFR Part 820)
Experience with software development life cycle processes, verification/validation practices, and risk-based quality engineering