Principal Systems Engineer - Hybrid - San Antonio, TX
$124,000–$170,500 year
Hybrid · San Antonio, Texas, United States
Job Summary
As a Principal Systems Engineer, you will focus on requirements engineering, system architecture, risk management, and V&V collaboration. You will manage system-level requirements, define system boundaries, and work with cross-functional teams to resolve design conflicts. You are expected to maintain operational knowledge of technologies and products while providing leadership throughout the product development lifecycle. A combined knowledge of both engineering and regulatory documentation is essential, along with experience in the medical device sector, particularly in a regulated environment.
Required 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
- OR High School Diploma/GED 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.
Desired Qualifications
- Experience with IEC 60601-1
- Experience with Graphical User Interface development
- Experience with wireless communications (Cellular, Bluetooth, WiFi)
- Experience driving continuous improvement of processes, tooling, and technical deliverables.
Additional Requirements
- Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
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