Principal Systems Engineer - Hybrid - San Antonio, TX

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

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges.

Job Title

Principal Systems Engineer - 3M Health Care is now Solventum

Impact You’ll Make in this Role

As a Principal Systems Engineering, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Requirements Engineering: Elicit, document, and manage system-level requirements, ensuring full traceability from user needs to low-level components.
• System Architecture: Define system boundaries, interfaces, and data flows between subsystems (e.g., embedded software, sensors, and mechanical assemblies).
• Risk Management: Actively participate in ISO 14971 risk management activities, including Hazard Analysis, DFMEA (Design Failure Mode and Effects Analysis), and Usability.
• V&V Collaboration: Work with V&V team to execute comprehensive Verification and Validation (V&V) strategies to prove the system meets all design inputs and intended uses.
• Cross-Functional Synthesis: Act as the technical bridge between Mechanical, Electrical, Software, and Quality teams to resolve design conflicts.
• Regulatory Documentation: Author and review technical files for global regulatory submissions (FDA 510(k), PMA, or EU MDR).
• Providing leadership and direction to technical team, guiding them through the stages of requirements definition, design, implementation, and validation to achieve coherent and efficient system architecture.
• Maintaining a strong operational knowledge of organization’s technologies, products, customers and customers’ needs.
• Perform technical planning, system design and architecture, evaluate alternatives including cost and risk, and supportability of total system.
• Developing an in-depth knowledge of product development, manufacturing, engineering, financial, legal, sales and marketing functions and interfaces as required.
• Managing product documentation through processes.
• Participating in all reasonable work activities deemed suitable and assigned by management.
• Conforming to, supporting and enforcing all Company policies and procedures.

Your Skills and Expertise

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor’s degree or higher (completed and verified prior to start) 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

In addition to the above requirements, the following are also required:

• 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.

Additional qualifications that could help you succeed in this role include:

• Experience with IEC 60601-1
• Experience with Graphical User Interface development.
• Experience with wireless communications (Cellular, Bluetooth, WiFi) and/or location services (GPS).
• Experience driving continuous improvement of processes, tooling, and technical deliverables.

Work location

Hybrid Eligible (Job Duties allow for some remote work but require travel to San Antonio, TX at least 3 days per week).

Travel

May include up to 10% domestic / international.

Relocation Assistance

May be authorized.

Legal and H1B

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Supporting Your Well‑being

Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. Applicable to US Applicants Only:

The expected compensation range for this position is $124,000 - $170,500, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience.

In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.).

Additional information is available at: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards

Role Responsibilities

Responsibilities of this position include compliance with corporate policies, procedures and security standards while performing assigned duties.

Equal Opportunity Statement

Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges.

As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.