Senior Software Quality Engineer – CST – Lafayette, CO (Onsite)

Medtronic•Lafayette, CO

11d•$103,200 - $154,800•Onsite

About The Position

Medtronic Cranial & Spinal Technologies (CST) empowers surgeons with connected technologies that improve precision, efficiency, and outcomes in complex spine and cranial procedures. This role supports AiBLE within the Cranial & Spinal Technologies Operating Unit. AiBLE combines artificial intelligence, machine learning, and advanced digital technologies to enhance surgical planning, navigation, workflow efficiency, and clinical decision-making across the CST portfolio. This position is based in Lafayette, Colorado and is expected to work onsite. Travel requirements are less than 10%.

Requirements

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 of Software Quality Engineering experience OR PhD and 0+ years of Software Quality Engineering experience.
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.

Nice To Haves

Experience in the medical device industry or another regulated industry with software quality requirements.
Knowledge of U.S. Food and Drug Administration regulations, IEC 62304, ISO 13485, and software development quality standards.
Experience with artificial intelligence-enabled software, Software as a Medical Device (SaMD), digital health technologies, or embedded software.
Experience with test automation tools, scripting languages such as Python, C++, or MATLAB, and data-driven testing approaches.
Knowledge of risk management principles, ISO 14971, design controls, and regulatory submission support activities.

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.