The Senior Product Development Engineer plays 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.
- Minimum of 5 years’ direct experience as a R&D/Manufacturing Engineer in a relevant environment (medical device and/or capital equipment).
- Bachelor of Science degree in mechanical, electrical, systems Engineering, Physics, or similar discipline.
- 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.
- Experience with radiation therapy beam systems highly desirable.
- Some domestic travel may be required.