Sr. Software Systems Engineer - Premarket Design Quality

Regulatory Jobs; Fridley (MN); On-site; USD 121,000 - 181,000; Full time

Benefits offered by this job

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

Simple Steps (global well-being)

Job summary

Medtronic seeks a Senior Software Systems Engineer to join the Neuromodulation and Pelvic Health Premarket Design Quality team. You will ensure software and system-level design activities comply with quality and regulatory requirements throughout the design control lifecycle.

Responsibilities include providing design quality support, reviewing requirements, developing verification/validation strategies, and mentoring engineers to enhance product quality, safety, and compliance across

Qualifications

• Bachelor's degree in Software Engineering, Computer Engineering, Electrical Engineering, Systems Engineering, or a related technical field with minimum 4 years of relevant experience OR Master's with 2+ years OR PhD with 0+ years.
• 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 teams

Responsibilities

• 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.
• Participate in the 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.
• Lead software-related risk evaluation and mitigation verification to support risk management activities, including hazard analysis
• 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.

Skills

Design controls

Software lifecycle

Risk management

Cross-functional collaboration

Education

Bachelor's degree in a related technical field

Master's degree in a related field

PhD in a related field

Job description

We anticipate the application window for this opening will close on - 11 Nov 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.

A Day in the Life

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 Premarket 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.
Key Responsibilities

• 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.
• Participate in the 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.
• Lead software-related risk evaluation and mitigation verification to support risk management activities, including hazard analysis
• 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.

Required Qualifications

• Bachelor's degreein 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 teams

Preferred Qualifications

• 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.

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):$120,800.00 - $181,200.00

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, andSimple 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), andCapital 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.