Identifies user needs through engagement with product users (often Orthopedic Surgeons) and observation of similar device usage
Translates targeted user needs into design requirements/inputs
Creates product designs which fully address targeted user needs/requirements, and authors design rationale to document basis of all design features
Prepares and reviews information for invention disclosures and patents
Initiates, provides instruction for and coordinates with support from Zimmer Biomet cross-functional team members in the production and inspection of product prototypes for preliminary evaluation; and final design verification, design validation and process validation
Creates product production specifications which appropriately account for design for manufacturability (process capability) and inspection
Identifies and documents critical to quality product features based on product intended use, design requirements, associated user risks and the design itself
Evaluates, verifies and validates product designs relative to design requirements and to reduce user risk in compliance (includes completing tolerance stack-ups, benchtop testing and executing simulated operating room cadaveric product evaluations)
Supports Zimmer Biomet Quality, Sourcing and Manufacturing teams with new product design transfer tasks for production of market release quantities
Develops new test methods and/or predictive modeling as required to evaluate new products, and complete test method validation
Authors, reviews, presents and obtains cross-functional team member approval of design control and risk management documentation
Supports Regulatory Affairs team with the creation of new product regulatory submission documentation, preparation of materials for and conducting pre-submission question regulatory meetings
Supports clinical affairs in the creation of clinical study plans and protocols for both new and market released products for regulatory submission and post-market surveillance