Principal Systems Engineer - HYBRID
Job Description & How to Apply Below
Who We Are
Refle Xion elevates radiopharmaceuticals from drugs that help identify cancer to guides that actively direct external beam radiotherapy by leveraging tumor biology. Designated an FDA Breakthrough Device for lung tumors, Refle Xion's SCINTIX biology-guided radiotherapy aims to overcome long-standing barriers preventing definitive radiotherapy for metastatic disease. FDA-cleared SCINTIX therapy automates targeting and motion management for use in FDG-guided treatment of lung and bone tumors that arise from primary lung and bone cancers or are metastases from other primary cancers.
In strategic collaborations with industry-leading radiopharmaceutical companies, Refle Xion is co-developing and co-commercializing disease-specific radiotracers for treating late-stage cancers.
Find out more about Refle Xion and SCINTIX therapy at
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About This Role
The Principal Systems Engineer will work closely with a broad cross-functional team to develop the product architecture and system-level design that meets customer needs while factoring in constraints and risks. The Principal Systems Engineer will provide technical expertise as a key member of Product Lifecycle Process (PLP) core team for active programs as well as guidance on the technology roadmap. The ideal candidate will be able to guide the team by applying quantitative techniques of analysis, modeling, and trade studies while partnering with subject matter experts.
This person will convey the design to a wide variety of audiences through informal and formal technical and design reviews and prepare technical descriptive documentation, test plans, and test reports.
What You Will Be Doing
Provide a system-level perspective to product development which translates customer and internal requirements to a system level design with specifications that are measurable and testable.Lead system level architecture investigations supported by quantitative analysis, modeling, and trade studies for current and next-generation radiotherapy products.Work with partner teams including Product Management, Clinical Physics, Quality Assurance, Regulatory Affairs, Subsystem teams, Manufacturing, and Service to define design requirements and interfaces, and understand impacts of designs regarding system performance as well as enterprise needs, constraints, risks, and priorities.Make complex technical decisions (risk tradeoffs, evaluation of trade studies, anomaly investigations, etc.) based on physical principles and experience.Communicate complex concepts to a wide variety of audiences.Bring clarity and direction to ambiguous technical problems.Responsible for system-level documentation defined in the Product Lifecycle Process, including specifications, verification test plans and reports, and design descriptions.Conduct and participate in technical and design reviews.Responsibilities may extend to reliability and sustaining engineering, manufacturing engineering in transfer to production, as well as issues escalated from installation and field service.Provide technical leadership, mentoring, training, and instruction as needed to the rest of the team.Other duties as assigned.Where You Will Do This Job
Hybrid - This position will allow the successful candidate to work on a Hybrid work location schedule. They must be based in the greater SF Bay Area and must be able to commute into the Refle Xion office in Hayward 1-4 days a week, depending on the role.
What We Need
Bachelor of Science (BS) degree in Physics, Engineering, or related field and at least 12 years of direct experience with complex, multidisciplinary systems - or -Master of Science (MS) in Physics, Engineering, or related field and at least 8 years of direct experience with complex, multidisciplinary systems - or -PhD in Physics, Engineering, or related field and at least 5 years of direct experience with complex, multidisciplinary systems.Hands-on experience with capital equipment consisting of complex electromechanical subsystems and embedded software.Experience in architectural level design of complex capital equipment and leading the development from early concept through to production.Demonstrated experience in meeting requirements of a Quality Management System and risk-based analysis.Experience in technical supervision of, or performance of assembly, test, troubleshooting, and design verification testing of complex systems.Experience with data-driven engineering methodology such as Failure Modes and Effects Analysis, reliability testing, and Design of Experiments.Experience with project management of technical root cause investigations and design verification activities.Ability to communicate and influence effectively across all levels and organizations.Dedication and determination to get through challenging problems in a fast-paced environment.Ways To Stand Out
Radiotherapy medical device…
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