Senior Systems Engineer, Medical Devices (Hybrid)

Solventum; San Antonio (TX); Hybrid; USD 124,000 - 171,000; Full time

Job summary

Solventum seeks a Principal Systems Engineer in San Antonio, TX to lead system requirements and architecture for embedded medical devices. You will collaborate across mechanical, electrical, software, and quality teams, ensuring design inputs are met and regulatory submissions are prepared.

The ideal candidate has extensive experience in regulated medical device development, hands-on C/C++ embedded systems, and strong risk management skills in a cross-functional setting.

Qualifications

• Bachelor's degree in engineering; minimum seven years combined industry experience in systems engineering and/or product design in a regulated environment.
• High School Diploma/GED; eleven years combined industry experience in systems engineering and/or product design in a regulated environment.
• 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.
• 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.

Responsibilities

• Requirements Engineering: Elicit, document, and manage system-level requirements with full traceability.
• System Architecture: Define system boundaries, interfaces, and data flows between subsystems.
• Risk Management: Participate in ISO 14971 activities including Hazard Analysis and DFMEA.
• V&V Collaboration: Work with V&V team to validate that the system meets design inputs.
• Cross-Functional Synthesis: Bridge Mechanical, Electrical, Software, and Quality teams to resolve conflicts.
• Regulatory Documentation: Prepare and review technical files for FDA 510(k), PMA, or EU MDR submissions.
• Provide leadership to technical team through requirements, design, implementation, and validation stages.
• Maintain knowledge of organization technologies, products, customers, and needs.
• Perform technical planning, system design and architecture, evaluate options for cost/risk and supportability.
• Develop knowledge of product development, manufacturing, finance, legal, sales, and marketing interfaces.
• Manage product documentation through processes.
• Participate in all reasonable work activities assigned by management.
• Conform to and enforce company policies and procedures.
• Travel and relocation may be required; hybrid work with travel to San Antonio as needed.

Skills

Embedded systems (C/C++)

Regulated environment experience

System requirements & architecture

Risk management (FDA/ISO)

V&V collaboration

Education

Bachelor's degree in engineering

High School Diploma/GED

Job description

Solventum seeks a Principal Systems Engineer in San Antonio, TX to lead system requirements and architecture for embedded medical devices. You will collaborate across mechanical, electrical, software, and quality teams, ensuring design inputs are met and regulatory submissions are prepared.

The ideal candidate has extensive experience in regulated medical device development, hands-on C/C++ embedded systems, and strong risk management skills in a cross-functional setting.