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

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

We anticipate the application window for this opening will close on - 26 Sep 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

At Medtronic Neuroscience, we are redefining what's possible in neurological and spinal care, bringing together innovation, expertise, and partnership to improve lives around the world.

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%.

Check us out on LinkedIn: Medtronic CST

As a Senior Software Design Quality Engineer, you will support the entire software development lifecycle (SDLC) of the AiBLE portfolio, ensuring software products meet quality, performance, and regulatory requirements from development through commercialization. Working closely with software, systems, and quality teams, you will drive quality throughout the product lifecycle by supporting verification and validation activities, ensuring compliance with design control requirements, and contributing to continuous improvement initiatives.

A Day in the Life

Primary 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.

Required 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 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.

Preferred Qualifications

• 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.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R.

• 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long‑term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$103,200.00 - $154,800.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well‑being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic Benefits And Compensation Plans

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.