Senior Software Development Quality Engineer

Job Title

SeniorSoftwareDevelopmentQuality 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 forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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.