Senior Software Quality Engineer – Onsite MedTech AI

Medtronic plc; Lafayette, Northern (CO, KY); Hybrid; USD 103,000 - 155,000; Full time

Job summary

Medtronic in Lafayette, Colorado is seeking a Senior Software Quality Engineer to support the AiBLE portfolio across the software development lifecycle, ensuring software quality, regulatory compliance, and traceability from development through commercialization. The role is onsite with travel under 10% and close collaboration with software, systems and quality teams.

The position requires a bachelor’s degree in engineering or computer science and 4+ years of software quality experience, with

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Software Engineering, or a technical discipline and 4+ years of Software Quality Engineering experience; OR Master’s degree and 2+ years; OR PhD and 0+ years.
• Experience supporting software verification and validation activities within a product development environment.
• Knowledge of software development lifecycle processes, software quality systems, and design control requirements.
• Experience reviewing technical documentation, requirements, test evidence, risk assessments, and change controls.
• Ability to effectively collaborate with cross-functional stakeholders to support product quality and compliance objectives.

Responsibilities

• Lead software quality engineering activities throughout the software development lifecycle, including requirements, design, development, integration, testing, release, and validation.
• Support the AiBLE portfolio by ensuring software products comply with quality system, regulatory, and product development requirements.
• Drive software verification and validation activities, ensuring traceability, test coverage, and alignment to system and software requirements.
• Review software architecture, design documentation, risk management documentation, and engineering changes to assess compliance with quality and regulatory expectations.
• Develop and maintain software quality processes, procedures, and standards to support compliant product development and commercialization.
• Analyze and monitor quality metrics to identify trends, assess product performance, and support continuous improvement efforts.
• Ensure design history files, validation records, and other project documentation meet quality standards and audit requirements.
• Partner with cross-functional teams to investigate, resolve, and prevent software quality issues throughout product development and post-market activities.

Job description

Medtronic in Lafayette, Colorado is seeking a Senior Software Quality Engineer to support the AiBLE portfolio across the software development lifecycle, ensuring software quality, regulatory compliance, and traceability from development through commercialization. The role is onsite with travel under 10% and close collaboration with software, systems and quality teams.

The position requires a bachelor’s degree in engineering or computer science and 4+ years of software quality experience, with