Sr. Development Engineer
Current-Leads cross-functional team through all phases of the design control process from concept to launch for surgical instruments and implants used in spine surgery-Creates and supports the development of prototypes and processes using in-house or external resources-Leverages CAD software or in-house rapid prototyping equipment to design medical devices and instruments suitable for a traditional, novel, and additive manufacturing methods-Specifies engineering drawings, including assignment of dimensions and tolerances to designs-Creates and maintains documentation relevant to design control and other applicable regulatory requirements-Documents technical assessments of mechanical design (eg FEA, tolerance analysis, testing, etc.)Supports manufacturing of viable designs using in-house rapid prototyping equipment or by outsourcing to external suppliers-Supports cadaver labs during surgeon education events, including cadaver setup, running a fluoroscopy machine, clean-up, etc-Adheres to project delivery schedules and performs duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485