Job Title: Sr. Product Development Engineer
Job Number: 70478
Location: , US
Under minimal supervision, primarily responsible for the design and development of new spinal products/product families and/or the enhancement of existing products. Involved in creating designs, modeling and drafting, utilizing a 3D CAD system. Other responsibilities include assisting in the development process with Marketing, Purchasing, Manufacturing, Quality, and Regulatory to help manage the project deliverables from conceptualization through full market launch.
* Research, develop, and design spinal implants & instruments in accordance with FDA and ISO requirements—New Product Development as well as maintenance of existing legacy systems. * Lead identification and timely execution of complete product development process and project deliverables, including concept design, testing, design finalization, verification/validation activities, transfer, and launch support. * Execute development activities of multiple line extensions and special instrument modifications in an abbreviated schedule simultaneously. * Create designs using CAD (SolidWorks) intended for both subtractive and additive manufacturing methods. Generate 3D part files, 3D assembly files, & 2D technical drawings. * Write protocols, execute, analyze test data, and generate reports to verify or validate that designs meet functional and performance specifications, including interactions with outside testing facilities. * Generates and manages the Change Order process for initial release & revision of device-related changes, including potential impacts on current design inputs, risk, and relevant controlled documents in the system Design History File. * Generates and manages the Change Order process for initial and updated revisions of appropriate Quality Management System documents and processes.
• Experience and Proficiency with CAD software required (SolidWorks preferred). • Full working knowledge & experience with product development cycle and phased/gate approach of small to medium projects. • Knowledge of general manufacturing processes, and familiarity with common materials and practices to produce medical implants and instruments. Experience with Additive Manufacturing preferred. • Experience with GD&T, stack-up analysis, and mechanical testing. • Experience and knowledge relevant ASTM, ISO, FDA standards, regulations, guidelines.
Application Deadline: 2023-12-25