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Jobs · Information Technology · Texas

Principal Systems Engineer - Hybrid - San Antonio, TX

Solventum · San Antonio, TX · 2 days ago
On-siteInformation Technology$124k–$171k/yrFull-time

About the Role

As a Principal Systems Engineer, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. You will act as the technical bridge between Mechanical, Electrical, Software, and Quality teams to resolve design conflicts and provide leadership and direction to technical teams through requirements definition, design, implementation, and validation to achieve coherent and efficient system architecture.

Key Responsibilities

  • 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.

Minimum 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
  • OR 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.

Preferred Qualifications

  • 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 & Travel

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.

Pay & Benefits

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 and may vary based on factors including relevant knowledge, training, skills, work location, and/or experience.

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.).

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