About the role
Design and implement product line extensions, working closely with the R&D, clinical, and regulatory teams. Champion Design for Manufacturing (DFM) improvements across launched product lines to optimize cost, reliability, and manufacturability. Resolve manufacturing challenges through vendor coordination and iterative design updates. Provide technical support during cadaver labs and customer engagement meetings to validate and refine device performance. Support surgical cases in the operating room, working directly with surgeons to gather real-time feedback and identify clinical opportunities for improvement. Perform product scrap analysis and coordinate remediation strategies to improve yield and performance. Conduct complaint evaluations, identify root causes, and implement corrective actions in collaboration with cross-functional teams. Lead and contribute to Post-Market Surveillance Reports (PMSR) and Periodic Safety Update Reports (PSUR) in compliance with global regulatory standards. Drive risk analyses to assess and mitigate design and process risks.