Software Development Quality Engineer

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 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 You’ll Work On

• 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/ML‑enabled 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 post‑market data and clinical feedback.

• Support design control deliverables for new product development, Software/firmware changes, Cybersecurity‑related updates.

• Apply risk‑based, structured problem‑solving to identify, prioritize, and resolve quality issues; participate in root‑cause 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

• Bachelor’s degree in Computer Science/Engineering, Biomedical Engineering, Electrical Engineering, or related technical discipline.

• Minimum 2 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 risk‑based quality engineering.

• 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 skills 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 cross‑functional collaboration skills.

• Advanced computer skills, including statistical/data analysis and report writing skills.

Preferred Qualifications

• Master’s degree in Engineering or related field.

• 3+ years of software development quality experience in a regulated industry.

• Experience with implantable Class III medical devices or safety‑critical embedded systems.

• Working knowledge of cybersecurity requirements, software configuration management, and requirements management tools (e.g., Polarion, Doors, Jira).

• Knowledge of AI/ML development, including understanding of model life cycle, data preprocessing, training, validation, and performance evaluation.

• 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).

• Experience with data‑driven problem solving, statistical analysis, or reliability engineering tools.