Principal Systems Engineer

Solventum • Maplewood, MN

8h • Hybrid

About The Position

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients’ lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you. The Impact You’ll Make in this Role 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 will drive system-level clarity, alignment, and execution across requirements, architecture, risk management, integration, verification/validation, and regulatory documentation. As a Principal Systems Engineer, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by: 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 (e.g., embedded software, sensors, connectivity, mechanical assemblies). Risk Management: Actively 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.

Requirements

• Bachelor’s degree or higher (completed and verified prior to start) in Engineering from an accredited institution and minimum of seven (7) years of combined industry experience in systems engineering and/or product design OR High School Diploma/GED (completed and verified prior to start) 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 (ie--- 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 .

Nice To Haves

• Experience with graphical user interface (GUI) development.
• Experience with wireless communications (cellular, Bluetooth, Wi-Fi) and/or location services (GPS).

Responsibilities

• Eliciting, documenting, and managing system-level requirements with full traceability from user needs through subsystem and component requirements.
• Defining system boundaries, interfaces, and data flows across subsystems (e.g., embedded software, sensors, connectivity, mechanical assemblies).
• Actively participating in ISO 14971 risk management activities, including hazard analysis, DFMEA, and usability-related risk assessments.
• Partnering with Verification & Validation teams to define and execute comprehensive V&V strategies that demonstrate the system meets design inputs and intended uses.
• Serving as the technical bridge across Mechanical, Electrical, Software, Quality, and Manufacturing teams to resolve tradeoffs, integration issues, and design conflicts.
• Authoring and reviewing technical documentation and technical files in support of global regulatory submissions (e.g., FDA 510(k)/PMA and EU MDR).
• Providing leadership and direction to technical teams, guiding requirements definition, design, implementation, integration, and validation to enable a coherent and efficient system architecture.
• Leading system-level planning, architecture decisions, and alternative evaluations, including cost, risk, and total system supportability.
• Maintaining strong knowledge of Solventum technologies, products, customers, and evolving customer needs to inform system decisions.
• 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.

Benefits

• Solventum offers many programs to help you live your best life, both physically and financially.
• To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.
• Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Principal