Senior Product Development Engineer - ONSITE

Job Description

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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The Senior Product Development Engineer will play a key role in the development, support, commercialization, and improvement of a complex electromechanical, radiation therapy medical device. Major objectives are to support the design, prototyping, and testing of product improvements, support the maintenance of Research & Development (R&D) devices, and to facilitate design transfer of R&D device improvements to manufacturing. This role requires demonstrated technical competence in systems engineering, system integration, and hands‑on system problem solving, technical depth in mechanical or electrical engineering, and very effective communication and interpersonal skills.

This role will serve as a primary engineering liaison between R&D and New Product Introduction (NPI) and will be an evolving position in a start‑up company environment.

• Gain systems-engineering level knowledge of highly‑complex medical device
• Execute R&D device activities including regular health checks, maintenance, troubleshooting and repair, system calibrations, Software/Hardware upgrades, revision control, testing, debugging and data analysis of measurement performance
• Keep performance and maintenance records on the equipment. Maintain physical configuration reports, and plan maintenance and upgrade paths
• Complete initial diagnosis of any system issue, drive to uncover root cause, and devise or drive a team to define solutions for complex problems. Support the detailed analysis and tradeoffs for the various solutions, develop plan of action, and effectively communicate plan to colleagues
• Support subsystem builds, full system builds, and system integration during product improvement developments, including hands‑on assembly
• Troubleshoot component/system failures during assembly and as part of corrective action investigations
• Help create and execute test plans for complex subsystems. This will involve integration of subsystems, testing against design tolerances and specifications, analyzing test data, and generation of reports
• Partner with R&D engineers to develop the assembly and test manufacturing documentation (Manufacturing Process Instructions (MPIs), travelers, Bill of Materials (BOM)) for product improvements and partner with NPI to transfer into routine manufacturing
• Other duties as assigned

• Onsite - This position requires the successful candidate to work from the Refle Xion office. They must be based in the greater SF Bay Area and must be able to commute into the Refle Xion office in Hayward daily.

• Minimum of 7 years' direct experience as a R&D and/or Manufacturing Engineer in a relevant environment (medical device and/or capital equipment)
• Bachelor of Science (BS) degree in mechanical, electrical, systems engineering, physics, or similar discipline OR 15 years direct, diagnostic / troubleshooting experience on complex capital equipment
• Experienced with integrating and troubleshooting complex electromechanical systems and related software
• Demonstrated experience with all phases of product development including design, bring‑up, debug, and transition to manufacturing
• Able to isolate…