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Principal Systems Engineer

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Solventum (3M Healthcare) logoSolventum (3m Healthcare) · Minnesota, Maplewood
Full-timeRemote2w ago
ComplianceDocumentationLeadershipRisk Management
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Additional Information

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Job Description: Principal Systems Engineer | Solventum 3M Health Care is now Solventum 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. Your Skills and Expertise To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications: 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 In addition to the above requirement


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