Principal Systems Engineer - Hybrid - San Antonio, TX

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.

Principal Systems Engineer - 3M Health Care is now Solventum

As a Principal Systems Engineering, 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:
  Elicit, document, and manage system-level requirements, ensuring full traceability from user needs to low-level components.
• System Architecture:
  Define system boundaries, interfaces, and data flows between subsystems (e.g., embedded software, sensors, and mechanical assemblies).
• Risk Management:
  
  Actively participate in ISO 14971 risk management activities, including Hazard Analysis, DFMEA (Design Failure Mode and Effects Analysis), and Usability.
• V&V
  
  Collaboration:
  
  Work with V&V team to execute comprehensive Verification and Validation (V&V) strategies to prove the system meets all design inputs and intended uses.
• Cross-Functional Synthesis:
  Act as the technical bridge between Mechanical, Electrical, Software, and Quality teams to resolve design conflicts.
• Regulatory Documentation:
  Author and review technical files for global regulatory submissions (FDA 510(k), PMA, or EU MDR).
• Providing leadership and direction to technical team, guiding them through the stages of requirements definition, design, implementation, and validation to achieve coherent and efficient system architecture.
• Maintaining a strong operational knowledge of organization’s technologies, products, customers and customers’ needs.
• Perform technical planning, system design and architecture, evaluate alternatives including cost and risk, and supportability of total system.
• Developing an in-depth knowledge of product development, manufacturing, engineering, financial, legal, sales and marketing functions and interfaces as required.
• Managing product documentation through processes.
• Participating in all reasonable work activities deemed suitable and assigned by management.
• Conforming to, supporting and enforcing all Company policies and procedures.

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 combined industry experience in systems engineering and/or product design in a regulated environment
• High School Diploma/GED (completed and verified prior to start) and eleven (11) years combined industry experience in systems engineering and/or product design in a regulated environment

In addition to the above requirements, the following are also required:

• Demonstrated understanding and experience in design, development, and testing of embedded, electro‑mechanical medical devices.
• Experience in a regulated design environment with medical device development, FDA or ISO registered work experience.
• Experience in GMP certified Manufacturing Processes and UL/IEC Standards.
• Hands‑on experience in System Engineering with working knowledge of C or C++ embedded systems, IoT Communication, and Cybersecurity risk management.
• Experience leading system requirements, architecture, integration, and testing through formal design reviews to final verification and validation.
• Experienc…