R&D Specialist

Kelly Engineering is 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 experience to join an innovative team based in Irvine, California .

This 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 role
• Lead the execution, audit, and closure of work orders
• Function as Project Coordinator for the Device History File of a project team
• Manage the supply chain for new product development materials
• Manage inventory of new product development materials
• Kit materials for new product development builds while maintaining traceability
• Maintain design control for new product development build activities
• Supports project team / technical projects and initiatives that focus on cost improvement, business continuity, process excellence to enable product development activities
• Support Compliance activities
• Responsible for coordinating and tracking training for team associates
• Monitor and report on project budget expenses
• Support the project team in the creation and reconciliation of purchase order requisitions
• Monitor and report on budget spend in anticipation of quarterly and fiscal year close
• Coordinate logistics and payment for physician engagements and project studies
• Coordinate requests for HCP & non-HCP engagement, travel, and research contracts
• Supports projects / initiatives to enable product development activities

Required Qualifications :