Principal Systems Engineer - Hybrid - San Antonio, TX

SOLVENTUM•San Antonio, TX

7d•$124,000 - $170,500•Hybrid

About The Position

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 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. 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.

Requirements

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

Nice To Haves

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.

Responsibilities

Elicit, document, and manage system-level requirements, ensuring full traceability from user needs to low-level components.
Define system boundaries, interfaces, and data flows between subsystems (e.g., embedded software, sensors, and mechanical assemblies).
Actively participate in ISO 14971 risk management activities, including Hazard Analysis, DFMEA (Design Failure Mode and Effects Analysis), and Usability.
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.
Act as the technical bridge between Mechanical, Electrical, Software, and Quality teams to resolve design conflicts.
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.