Principal Systems Engineer, Embedded R&D

SOLVENTUM•San Antonio, TX

1d•$124,000 - $170,500•Hybrid

About The Position

Solventum is seeking a Principal Systems Engineer for its Embedded R&D organization. The role supports new product development for embedded, electromechanical medical devices and serves as a technical bridge across Mechanical, Electrical, Software, Quality, and Verification and Validation (V&V) teams. The position is hybrid in San Antonio, Texas, with at least three days per week of travel to that location, and may involve up to 10% domestic or international travel. Relocation assistance may be authorized. The engineer defines and manages system requirements, architecture, interfaces, and data flows; leads technical planning and design reviews; supports risk management; and collaborates with V&V teams on verification and validation strategies. The role also reviews product-development documentation that supports global regulatory submissions, including FDA 510(k), PMA, and EU MDR. The position requires compliance with company policies, procedures, and security standards.

Requirements

Bachelor’s degree or higher in engineering from an accredited institution, completed and verified before starting, and at least seven years of combined industry experience in systems engineering and/or product design in a regulated environment; alternatively, a high school diploma or GED, completed and verified before starting, and at least eleven years of that combined experience.
Five years of demonstrated understanding and experience in the design, development, and testing of embedded electromechanical medical devices.
Five years of experience in a regulated design environment involving medical-device development, FDA work, or ISO-registered work.
Five years of experience with GMP-certified manufacturing processes and UL/IEC standards.
Two years of hands-on systems engineering experience with products involving C or C++ embedded systems, IoT communication, and/or cybersecurity risk management.
Must be legally authorized to work in the country of employment without employment-visa sponsorship.

Nice To Haves

Experience leading system requirements, architecture, integration, and testing through formal design reviews to final verification and validation.
Experience facilitating technical working sessions and engineering reviews.
Demonstrated experience identifying, quantifying, and mitigating technical risks.
Strong self-directed execution, problem-solving, and critical-thinking skills.
Experience with graphical user interface development.
Experience with wireless communications (cellular, Bluetooth, or Wi-Fi) and/or location services (GPS).
Experience driving continuous improvement of processes, tooling, and technical deliverables.

Responsibilities

Advise cross-functional new-product-development teams and serve as the technical bridge across Mechanical, Electrical, Software, Quality, and V&V teams.
Define and manage system requirements, architecture, interfaces, and data flows, ensuring end-to-end requirements traceability.
Lead technical planning, system design, and architecture reviews; evaluate alternatives based on performance, cost, risk, and supportability.
Support risk management activities, including Hazard Analysis, DFMEA, usability, and ISO 14971 requirements.
Collaborate with V&V teams to develop and execute verification and validation strategies against design inputs and intended use.
Review technical documentation supporting product development and global regulatory submissions, including FDA 510(k), PMA, and EU MDR.
Participate in reasonable work activities deemed suitable and assigned by management.
Conform to, support, and enforce company policies and procedures.
Comply with corporate policies, procedures, and security standards while performing assigned duties.