Sr. Software Systems Engineer

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 95000 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.

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.

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.

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.

• 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.

Required Qualifications

• Bachelors degreein Software Engineering Computer Engineering Electrical Engineering Systems Engineering or a related technical field and minimum of 4 years of relevant experience OR Masters 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

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 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.

Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind:

Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @ email addresses.

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.

If you receive a suspicious message claiming to be from Medtronic do not respond click links or open attachments.

If you have any questions concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic please contact us immediately at .

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.

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-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 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 findhere 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.