Principal Systems Engineer

Summary

Principal Systems Engineer leading full product development lifecycle for a Class II Medical Device, defining system architecture and engineering strategy across electrical, firmware, software, and manufacturing domains. Owns multidisciplinary systems end-to-end, establishing development processes (CI/CD, automated testing, version control), leading embedded hardware and firmware architectures, and ensuring FDA compliance and Design Controls adherence. Serves as primary technical authority coordinating internal teams and external partners, conducting design/architecture reviews, supporting manufacturing scale-up, and mentoring cross-functional engineers. Requires 12+ years of multidisciplinary product development with demonstrated systems engineering expertise, regulated-industry experience, and technical leadership without direct authority.