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

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., * 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.

• 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., * 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.

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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

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.

A Day in the Life

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 (https://www.linkedin.com/company/medtronic-brain-and-spine-therapies/posts/?feedView=all), 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 (https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/employee-support-services/careers/la-county-legal-notice.pdf) 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.

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.

We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…

• Build a better future, amplifying your impact on the causes that matter to you and the world
• Grow a career reflective of your passion and abilities
• Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest:

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You’re shaping the future of healthcare technology and defining the next generation of breakthroughs in care

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.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.