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

Medtronic•Lafayette, CO

2d•Onsite

About The Position

Medtronic’s Software Design Quality Engineer II supports the software development lifecycle of the AiBLE portfolio within Cranial & Spinal Technologies. The role helps ensure software products meet quality, performance, regulatory, and product-development requirements from development through commercialization. The engineer works closely with software, systems, and quality teams to support verification and validation, design control compliance, and continuous improvement. The position is based onsite in Lafayette, Colorado, with travel requirements of less than 10%.

Requirements

Bachelor’s degree in Engineering, Computer Science, Software Engineering, or a technical discipline and 2 or more years of Software Quality Engineering experience; or a master’s degree and 0 or more 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 collaborate effectively with cross-functional stakeholders to support product quality and compliance objectives.
For baccalaureate degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Roles below Principal level require unrestricted U.S. work authorization at the time of hire and for the duration of employment.

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 for 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.
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.

Benefits

Short-term incentive through the Medtronic Incentive Plan (MIP).
Health, dental, and vision insurance for eligible regular employees working 20 or more hours per week.
Health Savings Account.
Healthcare Flexible Spending Account.
Life insurance.
Long-term disability leave.
Dependent daycare spending account.
Tuition assistance or reimbursement.
Simple Steps global well-being program.
Incentive plans.
401(k) plan with employer contribution and match.
Short-term disability.
Paid time off.
Paid holidays.
Employee Stock Purchase Plan.
Employee Assistance Program.
Non-qualified Retirement Plan Supplement, subject to IRS earning minimums.
Capital Accumulation Plan for Vice Presidents and above, or subject to IRS earning minimums.