Senior Software Quality Engineer - AI-Driven SaMD

Medtronic; Louisiana (MO); On-site; USD 103,000 - 155,000; Full time

Job summary

Medtronic is seeking a Senior Software Design Quality Engineer for the AiBLE portfolio in the Cranial & Spinal Technologies unit. Based onsite in Lafayette, CO, you will lead software quality activities across the SDLC, ensuring compliance with design controls and regulatory standards while supporting verification and validation efforts.

You will collaborate with software, systems, and quality teams to improve processes, monitor quality metrics, and maintain audit-ready documentation.

Qualifications

• Bachelor’s degree in Engineering, CS, Software Engineering, or a technical discipline with 4+ years of Software Quality Engineering experience.
• Experience supporting software verification and validation activities.
• Knowledge of SDLC processes, software quality systems, and design control requirements.
• Experience reviewing technical documentation, requirements, test evidence, risk assessments, and change controls.
• Ability to collaborate with cross-functional stakeholders to support quality and compliance objectives.

Responsibilities

• Lead software quality engineering activities across the SDLC (requirements, design, development, integration, testing, release, validation).
• Ensure AiBLE portfolio complies with quality systems, regulatory, and product development requirements.
• Drive verification and validation activities with traceability and coverage alignment.
• Review architecture, design docs, risk management, and engineering changes for compliance.
• Develop and maintain software quality processes, procedures, and standards.
• Analyze quality metrics to identify trends and support continuous improvement.
• Ensure DHF, validation records, and project documentation meet quality standards.
• Partner with cross-functional teams to investigate and resolve software quality issues.

Skills

Software Quality Engineering

Verification & Validation

Cross-functional Collaboration

Regulatory Compliance

Education

Bachelor’s degree in Engineering / CS / Software

Master’s degree (optional)

PhD (optional)

Tools

Python

C++

MATLAB

Job description

Medtronic is seeking a Senior Software Design Quality Engineer for the AiBLE portfolio in the Cranial & Spinal Technologies unit. Based onsite in Lafayette, CO, you will lead software quality activities across the SDLC, ensuring compliance with design controls and regulatory standards while supporting verification and validation efforts.

You will collaborate with software, systems, and quality teams to improve processes, monitor quality metrics, and maintain audit-ready documentation.