Principal Systems Engineer (CAS)

Medtronic•Mounds View, MN

1d•$134,400 - $201,600•Onsite

About The Position

The Principal Systems Engineer will serve as a recognized technical leader for Medtronic’s Cardiac Ablation Solutions business, connecting customer and clinical needs with systems engineering across capital equipment, software, disposables, catheters, sheaths, accessories, and their interfaces. The role leads work throughout the product lifecycle, from early concept and architecture through design transfer, commercialization, post-market support, and product evolution. The engineer influences cross-functional decisions, resolves ambiguous system-level challenges, mentors technical teams, and strengthens systems engineering practices across CAS. The position is based in Mounds View, Minnesota, and works onsite four days per week. Travel is expected to be less than 10%.

Requirements

Bachelor’s degree in Engineering, Physics, or a related degree program.
At least 7 years of relevant experience; alternatively, a master’s degree with at least 5 years of relevant experience, or a PhD with 3 years of relevant experience.
For baccalaureate degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

Experience in the medical-device or another highly regulated industry, with 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.

Responsibilities

Lead systems engineering activities for complex, multidisciplinary medical-device programs and significant product changes.
Partner with Marketing, Clinical, Human Factors, Medical Safety, and field-facing teams to translate stakeholder needs, use cases, and use environments into system-level design inputs.
Define, evaluate, and maintain system architecture, functional decomposition, interfaces, operating modes, performance budgets, and design trade-offs across hardware, software, firmware, disposables, and accessories.
Lead development, review, allocation, and lifecycle management of stakeholder, system, subsystem, interface, and performance requirements, ensuring clarity, testability, consistency, and end-to-end traceability.
Integrate product safety, usability, reliability, cybersecurity, and software risk considerations into system design; ensure risk controls are implemented, traced, and verified.
Establish system verification and validation strategies, including methods, acceptance criteria, test architecture, evidence plans, and resolution of system-level anomalies.
Plan and lead architecture, requirements, and design reviews, trade studies, and technical decision forums; communicate conclusions, residual risks, and recommendations to project and functional leadership.
Lead cross-functional root-cause investigations and system-level troubleshooting for complex design, integration, field, manufacturing, supplier, and product-performance issues.
Support design changes, component obsolescence, CAPA and corrective actions, regulatory commitments, supplier changes, product enhancements, and continuity-of-supply initiatives.
Influence without direct authority, align global teams, and help programs balance patient safety, quality, performance, cost, schedule, manufacturability, and serviceability.
Mentor systems engineers and partner disciplines; create reusable methods, templates, models, and lessons learned to improve predictability and technical excellence.
Engage suppliers, consultants, laboratories, clinicians, and other external partners when specialized capabilities or system evidence are required.
Produce stakeholder and system requirements, interface requirements, and traceability evidence.
Develop system context, architecture, functional decomposition, use scenarios, and interface definitions.
Prepare technical trade studies, engineering analyses, performance budgets, and decision records.
Provide system risk contributions, risk-control traceability, and benefit-risk inputs.
Develop system verification and validation strategies, plans, protocols, reports, and anomaly dispositions.
Prepare formal design review content and objective evidence supporting phase or business decisions.
Provide technical assessments supporting regulatory submissions, audits, CAPA, field actions, and product changes.
Assess post-market system performance and recommend prioritized improvements.