Principal Systems Engineer (CAS)
About the role
A Day in the Life
Careers That Change Lives
The Cardiac Ablation Solutions business develops cardiac mapping and ablation technologies used to treat patients with abnormal heart rhythms. The Principal Systems Engineer will serve as a recognized technical leader, connecting customer and clinical needs with disciplined systems engineering across capital equipment, software, disposables, catheters, sheaths, accessories, and their interfaces.
This role operates across the full product lifecycle, from early concept and architecture through design transfer, commercialization, post-market support, and product evolution. The engineer will influence cross-functional decisions, resolve ambiguous system-level challenges, mentor technical teams, and strengthen systems engineering practices across CAS.
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working onsite 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects. This position will be located in Mounds View, MN.
- System leadership. Lead systems engineering activities for complex, multidisciplinary medical-device programs and significant product changes.
- Customer and clinical needs. Partner with Marketing, Clinical, Human Factors, Medical Safety, and field-facing teams to translate stakeholder needs, use cases, and use environments into clear system-level design inputs.
- Architecture and interfaces. Define, evaluate, and maintain system architecture, functional decomposition, interfaces, operating modes, performance budgets, and key design trade-offs across hardware, software, firmware, disposables, and accessories.
- Requirements and traceability. Lead development, review, allocation, and lifecycle management of stakeholder, system, subsystem, interface, and performance requirements, ensuring clarity, testability, consistency, and end-to-end traceability.
- Risk management. Integrate product safety, usability, reliability, cybersecurity, and software risk considerations into system design; ensure risk controls are appropriately implemented, traced, and verified.
- Verification and validation. Establish system verification and validation strategies, including methods, acceptance criteria, test architecture, evidence plans, and resolution of system-level anomalies.
- Technical reviews. Plan and lead architecture reviews, requirements reviews, design reviews, trade studies, and technical decision forums. Communicate conclusions, residual risks, and recommendations to project and functional leadership.
- Problem solving. Lead cross-functional root-cause investigations and system-level troubleshooting for complex design, integration, field, manufacturing, supplier, and product-performance issues.
- Lifecycle stewardship. Support design changes, component obsolescence, CAPA and corrective actions, regulatory commitments, supplier changes, product enhancements, and continuity-of-supply initiatives.
- Technical influence. Serve as a technical authority who influences without direct authority, aligns global teams, and helps programs make balanced decisions across patient safety, quality, performance, cost, schedule, manufacturability, and serviceability.
- Capability building. Mentor systems engineers and partner disciplines; create reusable methods, templates, models, and lessons learned that improve predictability and technical excellence.
- External collaboration. Engage suppliers, consultants, laboratories, clinicians, and other external partners when specialized capabilities or system evidence are required.
Key Deliverables
- Stakeholder and system requirements, interface requirements, and traceability evidence
- System context, architecture, functional decomposition, use scenarios, and interface definitions
- Technical trade studies, engineering analyses, performance budgets, and decision records
- System risk contributions, risk-control traceability, and benefit-risk inputs
- System verification and validation strategies, plans, protocols, reports, and anomaly dispositions
- Formal design review content and objective evidence supporting phase or business decisions
- Technical assessments supporting regulatory submissions, audits, CAPA, field actions, and product changes
- Post-market system performance assessments and prioritized improvement recommendations.
Must Have: Minimum Requirements - To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
- Bachelors degree in Engineering, Physics, or a related degree program required.
- Minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience.
Nice to Have (Preferred Qualifications)
- Experience in the medical-device or other highly regulated industry and familiarity with design controls and product lifecycle processes.
- Experience with cardiac electrophysiology, cardiac mapping, ablation energy delivery, therapeutic catheters, sheaths, generators, navigation or visualization systems, or related accessories.
- Working knowledge of medical-device risk management, usability engineering, software lifecycle, electrical medical equipment, cybersecurity, and quality-system expectations.
- Experience with requirements and application-lifecycle tools such as Polarion, Jama Connect, IBM Engineering Requirements Management DOORS, or equivalent.
- Experience with model-based systems engineering, SysML, architecture frameworks, simulation, or system modeling tools.
- Practical experience with Design for Reliability and Manufacturability, statistical methods, test method development, root-cause analysis, and structured problem solving.
- Experience supporting regulatory submissions, notified-body or agency interactions, audits, CAPA, complaint investigations, or field corrective actions.
- Demonstrated mentoring, coaching, and technical-community leadership across global or distributed teams.
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About Medtronic
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