Senior Systems Engineer - Medical Devices & Regulated Design

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

Benefits offered by this job

Hybrid eligible

Relocation assistance

Job summary

Solventum, a healthcare company, is seeking a Principal Systems Engineer to drive system architecture for embedded medical devices. The role requires leading cross‑disciplinary teams through requirements, design, and validation while navigating regulatory standards (FDA/ISO).

Hybrid travel to San Antonio is expected, with a compensation range tied to market norms. The candidate will manage risk analyses, ensure traceability, and coordinate with Mechanical, Electrical, Software, and Quality

Qualifications

• Bachelor’s degree or higher 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
• 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
• 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
• Experience with IEC 60601-1
• Experience with Graphical User Interface development
• Experience with wireless communications and/or location services
• Experience driving continuous improvement of processes, tooling, and technical deliverables

Responsibilities

• Elicit, document, and manage system‑level requirements with full traceability
• Define system boundaries, interfaces, and data flows between subsystems
• Lead ISO 14971 risk management activities including Hazard Analysis and DFMEA
• Collaborate with V&V to prove system meets design inputs and uses
• Bridge Mechanical, Electrical, Software, and Quality teams to resolve design conflicts
• Contribute to regulatory documentation for FDA/ISO submissions
• Provide leadership to technical teams through requirements, design, implementation, and validation
• Maintain operational knowledge of technologies, products, and customer needs

Skills

Embedded systems

C/C++ programming

Systems engineering

Regulated medical devices

Risk management

Education

Bachelor’s degree in engineering

High School Diploma/GED with 11 years experience

Tools

ISO 14971

Job description

Solventum, a healthcare company, is seeking a Principal Systems Engineer to drive system architecture for embedded medical devices. The role requires leading cross‑disciplinary teams through requirements, design, and validation while navigating regulatory standards (FDA/ISO).

Hybrid travel to San Antonio is expected, with a compensation range tied to market norms. The candidate will manage risk analyses, ensure traceability, and coordinate with Mechanical, Electrical, Software, and Quality