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Senior Product Development Engineer

2 months ago

Hayward, California, United States BioSpace, Inc. Full time
About This Role

The Senior Product Development Engineer will play a pivotal role in the development, support, commercialization, and improvement of a sophisticated electromechanical, radiation therapy medical device. Key objectives include supporting the design, prototyping, and testing of product enhancements, maintaining Research & Development (R&D) devices, and facilitating design transfer of R&D device improvements to manufacturing.

Responsibilities
  • Gain systems-engineering level knowledge of highly-complex medical devices
  • 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
Requirements
  • 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 and debug hardware and software problems in complex systems
  • Demonstrated competency and understanding of system electronics
  • Expertise with electrical test equipment including logic analyzers, oscilloscopes, and digital multi-meters
  • Strong attention to detail and organizational skills
  • Strong communication and documentation skills
  • Ability to be proactive and collaborative in a dynamic start-up environment
  • Ability to work on your feet, standing for long periods of time
  • Must be able to safely lift 50 lbs
  • Occasional domestic travel may be required
Preferred Qualifications
  • Experience with radiation therapy beam systems highly desirable
  • Previous experience working in a highly regulated environment and familiarity with FDA requirements
About RefleXion

RefleXion is an innovative company that elevates radiopharmaceuticals from drugs that help identify cancer to guides that actively direct external beam radiotherapy by leveraging tumor biology. Our SCINTIX biology-guided radiotherapy aims to overcome long-standing barriers preventing definitive radiotherapy for metastatic disease.

We are committed to providing a dynamic and inclusive work environment that fosters collaboration, creativity, and growth. Our team is passionate about developing cutting-edge medical devices that improve patient outcomes and quality of life.

At RefleXion, we offer a competitive compensation package, including medical, dental, and vision benefits, as well as a 401(k) plan and employee assistance program. We also provide opportunities for professional growth and development, including training and education programs.

Join our team and be part of a mission to revolutionize cancer treatment and improve patient lives.