The Manufacturing Engineer, System Test plays a key role in implementing best-in-class manufacturing system test for a revolutionary radiation therapy medical device. Major objectives are to transfer, formally qualify, and routinize the system test processes to support commercial launch and meet company objectives for quality, delivery and cost. The successful candidate will demonstrate a solid understanding of system test considerations for complex, high-power, permanently installed capital equipment. This role will serve as the primary system test lead for Manufacturing and will be an evolving position in an exciting start-up company environment.
Partner with R&D engineers to develop the test processes for new products and transfer into routine manufacturing
Generate detailed system test and Factory Acceptance Test (FAT) documentation (MPI’s, travelers, BOM’s), and conduct training for technicians as needed
Work with design engineering to develop equipment, fixtures and tools to meet quality, safety and performance objectives
Ensure product quality by implementing effective process controls and conduct pFMEA risk assessments.
Implement Lean manufacturing practices to optimize product quality and manufacturing efficiencies.
Execute process validation through IQ, OQ, PQ, PPQ and TMV.
Support development of Customer Acceptance Test & Subsystem tests for Field Service
Ensure manufacturing compliance with all Safety and Quality regulations.
Debug and diagnose functional issues to the subsystem level, for both the hardware and software.
Generate engineering reports, justifications and MTF’s to support ECO’s, NCR’s, complaints and CAPA’s.
Drive design and process optimization for help with our design for system test and continuous improvement activities.
BS required Engineering, Physics or Science
Minimum of 5 years direct experience as a Manufacturing, NPI, R&D engineer, or Medical Physics
Experience integrating complex equipment involving Medical Accelerators, CT Scanners and/or PET scanners
Extensive experience using software driven tests of equipment.
Working knowledge of FDA QSR’s and ISO 13485
Experience performing pFMEA, IQ, OQ, PQ, PPQ, and TMV
Experience with data driven engineering methodologies such as DOE, GRR, SPC and 6 Sigma
Experience interacting with field service and/or hospital staff to qualify equipment
High attention to detail and organizational skills