Senior Embedded Systems Engineer – Medical Devices (Hybrid)

3mcompany; San Antonio (TX); Hybrid; USD 124,000 - 171,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Solventum in the United States is seeking a Principal Systems Engineer, Embedded R&D to lead cross-disciplinary product development for medical devices. You will define requirements, architect systems, and drive end-to-end verification with V&V teams in a hybrid San Antonio setting.

Qualifications include 7+ years in regulated engineering, strong C/C++ embedded experience, and familiarity with FDA/ISO processes.

Qualifications

• Engineering degree with 7+ years systems engineering in regulated environments.
• 5+ years in embedded electro-mechanical medical devices.
• 5+ years in GMP manufacturing and UL/IEC standards.
• 2+ years in system engineering with C/C++ embedded, IoT, or cybersecurity.
• Experience with FDA/ISO regulatory submissions and V&V.

Responsibilities

• Advise cross-functional teams on new product development across Mechanical, Electrical, Software, Quality, and V&V.
• Define and manage system requirements, architecture, interfaces, data flows with traceability.
• Lead design reviews and assess alternatives for performance, cost, risk, and supportability.
• Support risk management incl. Hazard Analysis, DFMEA, usability, ISO 14971.
• Collaborate with V&V to develop verification and validation strategies.
• Review documentation for regulatory submissions (FDA 510(k), PMA, EU MDR).

Skills

Embedded systems

C/C++ programming

IoT communications

Cybersecurity risk management

Regulated environment experience

Education

Engineering degree (Bachelor’s or higher)

High School Diploma with 11+ years experience in systems engineering

Tools

FDA/ISO regulatory submissions knowledge

V&V processes

C/C++ embedded systems experience

Job description

Solventum in the United States is seeking a Principal Systems Engineer, Embedded R&D to lead cross-disciplinary product development for medical devices. You will define requirements, architect systems, and drive end-to-end verification with V&V teams in a hybrid San Antonio setting.

Qualifications include 7+ years in regulated engineering, strong C/C++ embedded experience, and familiarity with FDA/ISO processes.