Principal Systems Engineer

Principal Systems Engineer – Solventum

As a Principal Systems Engineer, you will provide technical leadership across the full product lifecycle for embedded, electro‑mechanical medical devices in a regulated environment. You'll drive system‑level clarity, alignment, and execution across requirements, architecture, risk management, integration, verification/validation, and regulatory documentation.

Responsibilities:

• Requirements Engineering: Eliciting, documenting, and managing system‑level requirements with full traceability from user needs through subsystem and component requirements.
• System Architecture: Defining system boundaries, interfaces, and data flows across subsystems such as embedded software, sensors, connectivity, and mechanical assemblies.
• Risk Management: Participating in ISO 14971 risk management activities, including hazard analysis, DFMEA, and usability‑related risk assessments.
• V & V
  
  Collaboration:
  
  Partnering with Verification & Validation teams to define and execute comprehensive V & V strategies that demonstrate the system meets design inputs and intended uses.
• Cross‑Functional Integration: Serving as the technical bridge across Mechanical, Electrical, Software, Quality, and Manufacturing teams to resolve tradeoffs, integration issues, and design conflicts.
• Regulatory Documentation: Authoring and reviewing technical documentation and technical files in support of global regulatory submissions (e.g., FDA 510(k)/PMA and EU MDR).
• Technical Leadership: Providing leadership and direction to technical teams, guiding requirements definition, design, implementation, integration, and validation to enable a coherent and efficient system architecture.
• Technical Planning & Alternatives Assessment: Leading system‑level planning, architecture decisions, and alternative evaluations, including cost, risk, and total system supportability.
• Operational & Customer Insight: Maintaining strong knowledge of Solventum technologies, products, customers, and evolving customer needs to inform system decisions.
• Lifecycle & Documentation Management: Managing product documentation through established processes and ensuring compliance with quality system requirements.
• Driving continuous improvement in systems engineering processes, tools, and technical deliverables.
• Performing additional responsibilities as assigned and conforming to, supporting, and enforcing all company policies and procedures.

• Bachelor’s degree or higher in Engineering from an accredited institution and a minimum of seven (7) years of combined industry experience in systems engineering and/or product design OR high school diploma/GED and eleven (11) years of combined industry experience in systems engineering.
• Demonstrated understanding and experience in design, development, and testing of embedded, electro‑mechanical medical devices.
• Experience working in a regulated design environment, including medical device development within FDA and/or ISO‑registered quality systems; exposure to GMP manufacturing processes and applicable UL/IEC standards.
• Hands‑on systems engineering experience (e.g., working knowledge of C or C++ embedded systems, IoT communications, and cybersecurity risk management).
• Experience leading system requirements, architecture, integration, and test activities through formal design reviews to final verification and validation.
• Experience facilitating technical working sessions and engineering reviews.
• Proven experience identifying, quantifying, and mitigating technical risks.
• Experience driving continuous improvement of processes, tooling, and technical deliverables.
• Strong self‑directed execution, problem‑solving, and critical‑thinking skills.
• Experience with IEC 60601‑1.
• Additional qualifications that could help succeed:
  Experience with graphical user interface (GUI) development, wireless communications (cellular, Bluetooth, Wi‑Fi) and/or location services (GPS).

Hybrid eligible – duties allow for some remote work but require travel to Eagan, MN at least three (3) days per week.

Travel may include up to 10% domestic and/or international travel.

The expected compensation range for this position is $124,000 – $170,500, including base pay plus variable incentive pay if eligible.

Benefits may include medical, dental & vision, health savings accounts, health care & dependent care flexible spending accounts, disability benefits, life insurance, voluntary benefits, paid absences, retirement benefits, and more.

Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.