Onsite Senior Software Quality Engineer - AI/ML SaMD

Medtronic; Lafayette (CO); On-site; USD 103,000 - 155,000; Full time

Benefits offered by this job

Health Insurance

Dental & Vision

401(k) Plan

Paid Time Off

Job summary

Medtronic CST in Lafayette, CO, is seeking a Senior Software Design Quality Engineer to oversee the AI-enabled portfolio across the software development lifecycle, ensuring quality, performance, and regulatory compliance from development through commercialization.

You will collaborate with software, systems, and quality teams to drive verification and validation activities, maintain design controls, and contribute to continuous improvement initiatives.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Software Engineering, or a technical discipline with 4+ years in Software Quality Engineering; or Master’s with 2+ years; or PhD with 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 collaborate effectively with cross-functional stakeholders to support quality and compliance objectives.

Responsibilities

• Lead software quality engineering activities across the SDLC, including requirements, design, development, integration, testing, release, and validation.
• Support the AiBLE portfolio by ensuring software products comply with quality systems, regulatory, and product development requirements.
• Drive software verification and validation activities with traceability and test coverage aligned to requirements.
• Review architecture, design and risk management documentation for compliance with quality expectations.
• Develop and maintain software quality processes, procedures, and standards for compliant product development.
• Analyze quality metrics to identify trends and support continuous improvement.
• Ensure DHFs, validation records, and project documents meet quality standards and audit requirements.
• Partner with cross-functional teams to investigate and resolve software quality issues throughout development and post-market.

Skills

Software Quality Engineering

Verification & Validation

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s degree in Engineering or CS

Master’s degree (optional)

Tools

Python

C++

MATLAB

Job description

Medtronic CST in Lafayette, CO, is seeking a Senior Software Design Quality Engineer to oversee the AI-enabled portfolio across the software development lifecycle, ensuring quality, performance, and regulatory compliance from development through commercialization.

You will collaborate with software, systems, and quality teams to drive verification and validation activities, maintain design controls, and contribute to continuous improvement initiatives.