JD - Product Engineer
Job Title: Product Engineer
Position Summary
We are seeking a hands-on Product Engineer to support the development of innovative spinal implant systems, including 3D printed interbody fusion cages, pedicle screw systems, anterior cervical plates, and MIS (Minimally Invasive Surgery) interbody fusion devices and associated surgical instruments. The ideal candidate will work closely with clinical partners to identify usability and performance improvements, translate feedback into actionable design inputs, and coordinate with internal and external teams to drive product refinement.
Key Responsibilities
l Collect and organize surgeon feedback during lab evaluations and clinical use of spinal implant systems, including: 3D printed interbody fusion cages; Pedicle screw systems; Anterior cervical plate systems; MIS interbody fusion devices; Associated surgical instruments and instrument trays.
l Identify improvement opportunities in implant and instrument design, usability, ergonomics, and workflow.
l Assist in the development of training materials and surgical technique guides.
l Support regulatory documentation and risk analysis related to design modifications.
l Bachelor’s degree in Mechanical, Biomedical, or related Engineering field.
l Familiarity with surgical workflow and operating room environment.
l Strong communication skills for interacting with surgeons and cross-functional teams.
l Basic proficiency in CAD (SolidWorks, or equivalent) and design documentation.
l Understanding of design controls, usability engineering, and risk management processes.
l Prior involvement in surgeon evaluation sessions or cadaver labs.
l Knowledge of additive manufacturing (3D printing) technologies for medical implants.
l Experience in FDA Class II device development under ISO 13485/QSR environment.