R&D Specialist

Kelly Engineeringis hiring an R&D Specialist for a long-term contract at one of our Global Medical Device clients. We are searching for a driven and detail-oriented R&D Specialist with medical device industry experienceto join an innovative team based in Irvine, CaliforniaThis position is a specialist in supporting project teams in the development of electrophysiology catheters and/or related accessories. The project coordinator works directly with the team to coordinate activities related to new product development and the lifecycle. Key Responsibilities:Manufacturing line support and DHR audit experience Being a self-starter is important in this roleLead the execution, audit, and closure of work ordersFunction as Project Coordinator for the Device History File of a project teamManage the supply chain for new product development materialsManage inventory of new product development materialsKit materials for new product development builds while maintaining traceabilityMaintain design control for new product development build activitiesSupports project team/ technical projects and initiatives that focus on cost improvement, business continuity, process excellence to enable product development activitiesSupport Compliance activitiesResponsible for coordinating and tracking training for team associatesMonitor and report on project budget expensesSupport the project team in the creation and reconciliation of purchase order requisitionsMonitor and report on budget spend in anticipation of quarterly and fiscal year closeCoordinate logistics and payment for physician engagements and project studiesCoordinate requests for HCP & non-HCP engagement, travel, and research contractsSupports projects/ initiatives to enable product development activitiesRequired Qualifications:Medical device experience is requiredManufacturing line support and DHR audit experience In-depth knowledge of MS Office (i.e. Excel, Word, Outlook, and PowerPoint)Knowledge of PLM systems (i.e. JDE, Windchill)Ability to work with internal engineers & external vendors, detail-oriented to track progressExcellent verbal and written communication skillsExceptional aptitude in multitaskingIn depth understanding of specialized area to support new product development and lifecycle management (Product structure, Bills of Material, routings, etc.)Decision-making abilitySelf-motivated and project-oriented, whether independently or with a teamGood sense of urgencyStrong technical skills are requiredKnowledge and experience in product development processes a plusLocate sources for engineering materials and services, obtain quotes and place orders for material and servicesSupport communication activities regarding R&D initiativesSome program management duties as assignedMust be able to provide and utilize your own laptop

Created: 2025-09-25