Software Systems Engineer

Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey.

The Senior Software Systems Engineer on the Neuromodulation and Pelvic Health Pre-Market Design Quality team will partner with cross-functional development teams to ensure software and system-level design activities are planned, executed, and documented in compliance with applicable quality and regulatory requirements.

This role supports new product development by providing quality oversight and technical guidance throughout the design control lifecycle, with a focus on software-intensive medical device systems., * Provide design quality support for software and software-enabled medical device development programs from concept through transfer to manufacturing.

• Ensure compliance with applicable design control, software lifecycle, and risk management requirements.
• Review and contribute to system requirements, software requirements, architecture, and design documentation.
• Support development of verification and validation strategies for software, system, and integration testing.
• Partner with engineering, product development, regulatory, clinical, manufacturing, and quality teams to resolve design quality issues.
• Evaluate software development deliverables for completeness, traceability, and regulatory readiness.
• Support risk management activities, including hazard analysis, software-related risk evaluation, and mitigation verification.
• Participate in design reviews and provide constructive feedback to improve product quality, safety, and compliance.
• Assist in root cause analysis and corrective action activities related to design or software quality issues.
• Mentor less experienced engineers on design quality practices, documentation expectations, and compliance requirements.
• Contribute to continuous improvement initiatives for design quality processes, tools, and templates.

The ideal candidate combines strong systems engineering and software development knowledge with experience in design controls, risk management, verification and validation, and regulatory expectations for medical device development., * Bachelor’s degree in Software Engineering, Computer Engineering, Electrical Engineering, Systems Engineering, or a related technical field and minimum of 4 years of relevant experience OR Master’s degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.

• Demonstrated experience with design controls, software development lifecycle activities, and verification/validation.
• Strong understanding of risk management principles, design failure analysis concepts, and traceability across requirements, design, and testing.
• Experience supporting cross-functional product development teamss, * Strong written and verbal communication skills with the ability to influence and collaborate effectively.
• Ability to manage multiple priorities in a fast-paced environment.
• Experience in software engineering, systems engineering, design assurance, reliability, or quality engineering in a regulated industry.
• Experience in the medical device industry or another highly regulated environment.
• Knowledge of IEC 62304, ISO 14971, ISO 13485, FDA design control expectations, and related standards.
• Familiarity with agile development environments and how quality practices integrate into iterative development.
• Experience with AI used in process development and embedded in products
• Experience with software architecture reviews, cybersecurity considerations, or usability/human factors support.
• Advanced degree in engineering or a related discipline.

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):$120,800.00 - $181,200.00

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

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.