Senior Software Development Quality Engineer

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. Our 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Job Title Senior Software Development Quality Engineer Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. Youll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelors degree. A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This onsite role is based in Plano, TX, supporting the Neuromodulation division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum. As a Senior Software Development Quality Engineer, you will serve as a quality champion within product development, ensuring that software and system designs meet the highest standards of patient safety, product reliability, regulatory compliance, and clinical effectiveness. You will drive adherence to global regulations and standards, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, and EU MDR. What Youll Work On (Key Responsibilities) Serve as the primary quality representative on cross-functional development teams for software-enabled implantable medical devices. Ensure all product development activities comply with design control requirements and align with patient safety and clinical performance objectives. Review and approve requirements, design, development and verification/validation deliverables in compliance with FDA QSR requirements and applicable ISO/IEC standards. Ensure compliance with IEC 62304 software lifecycle processes, including software safety classification, Software development planning, requirements, architecture, detailed design, integration testing, system and software level verification, maintenance, and issue resolution. Provide quality engineering oversight for AI/MLenabled software features, ensuring model design, training, and validation aligned with regulatory and safety expectations for medical devices. Evaluate risk controls and ensure traceability between hazards, requirements, risk mitigations, and verification evidence. Lead Risk Management activities (ISO 14971) including risk management plan/report, hazard analysis and Software FMECA. Ensure continuous risk acceptability through analysis of postmarket data and clinical feedback. Support design control deliverables for new product development, Software/firmware changes, Cybersecurityrelated updates. Apply riskbased, structured problemsolving to identify, prioritize, and resolve quality issues; participate in rootcause investigations and drive effective corrective/preventive actions. Ensure integrity and completeness of the Design History File (DHF) and alignment with FDA Quality System Regulation (QSR) and ISO 13485 requirements. Participate in internal and external audits, and support regulatory submissions. Champion continuous improvement in software quality processes, contribute to updates of risk management processes, design control workflows, and software validation best practices. Accountable for Applicable Standards Document & checklists, Labeling Verification planning & execution, Essential Output reports, and General Safety and Performance Requirements (GSPR). Required Qualifications Bachelors 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 (medical devices preferred). Experience with software development life cycle processes, verification/validation practices, and riskbased quality engineering. Strong understanding of medical device regulatory frameworks, including IEC 62304, ISO 14971, ISO 13485, and/or FDA 21 CFR Part 820 design control requirements. Strong analytical/problem solving with proven ability to assess technical information, challenge design decisions objectively, and ensure compliance. Consistently demonstrates initiative, ownership and accountability Excellent communication, critical thinking, and crossfunctional collaboration skills. Advanced computer skills, including statistical/data analysis and report writing skills. Preferred Qualifications Masters degree in Engineering or related field. Experience with implantable Class III medical devices or safetycritical embedded systems. Highly preferred experience with AI/ML development, including understanding of model life cycle, data preprocessing, training, validation, and performance evaluation. Working knowledge of regulatory expectations for AI/ML medical devices, including FDA guidance on AI/MLenabled SaMD and GMLP principles. Ability to assess ML model risks and review technical documentation for datasets, algorithms, and model performance testing. Understanding of tools used in ML workflow management (e.g., MLFlow, TensorFlow, MLOps pipelines). Working knowledge of cybersecurity requirements, software configuration management, and requirements management tools (e.g., Polarion, Doors, Jira). Experience participating in regulatory audits (FDA, Notified Bodies). Experience with datadriven problem solving, statistical analysis, or reliability engineering tools. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com 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 www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews. The base pay for this position is $86,700.00 $173,300.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: NM Neuromodulation LOCATION: United States > Texas > Plano : 6901 Preston Road ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT 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. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter