Principal Systems Engineer

Principal Systems Engineer - Hybrid - San Antonio, TX

Principal Systems Engineer

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 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.

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 combined industry experience in systems engineering and/or product design in a regulated environment

OR

• 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

AND

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 environ