Principal Systems Engineer, Embedded R&D

Solventum•San Antonio, TX

3d•Hybrid

About The Position

Solventum is seeking a Principal Systems Engineer for its Embedded R&D team. The role provides systems engineering leadership for regulated medical-device product development, serving as a technical bridge among Mechanical, Electrical, Software, Quality, and Verification and Validation teams. The engineer defines and manages system requirements, architecture, interfaces, and data flows, and ensures end-to-end requirements traceability. The position leads technical planning, system design and architecture reviews, and evaluation of alternatives based on performance, cost, risk, and supportability. The role supports risk management, including Hazard Analysis, DFMEA, usability, and ISO 14971 requirements, and collaborates with V&V teams on verification and validation strategies aligned with design inputs and intended use. It also reviews technical documentation for product development and global regulatory submissions, including FDA 510(k), PMA, and EU MDR. The employee must follow company policies, procedures, and security standards and undertake other suitable work activities assigned by management. The position is based in San Antonio, Texas, with a hybrid arrangement requiring travel to the San Antonio location at least three days per week. Travel may be up to 10% domestic or international. Relocation assistance may be authorized. Applicants must be legally authorized to work in the country of employment without employment-visa sponsorship.

Requirements

Bachelor’s degree or higher in engineering from an accredited institution, completed and verified before starting, plus 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, plus at least eleven years of such 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 with medical-device development and FDA or ISO-registered work experience.
Five years of experience in GMP-certified manufacturing processes and UL/IEC standards.
Two years of hands-on systems engineering experience with products that include 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.
Proven 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 such as cellular, Bluetooth, or WiFi, and/or location services such as GPS.
Experience driving continuous improvement of processes, tooling, and technical deliverables.

Responsibilities

Advise cross-functional product-development teams and serve as the technical bridge among 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 for 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.
Comply with, support, and enforce company policies and procedures, including applicable corporate policies, procedures, and security standards.