Principal Systems Engineer - Hybrid - San Antonio, TX

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

Job Description

3M Health Care is now Solventum

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

Principal Systems Engineer

The Impact You'll Make in this Role

• 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

AND 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.

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

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

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.

Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.