Job Description

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:

• Medical device experience is required
• Manufacturing 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 progress
• Excellent verbal and written communication skills
• Exceptional aptitude in multitasking
• In depth understanding of specialized area to support new product development and lifecycle management (Product structure, Bills of Material, routings, etc.)
• Decision-making ability
• Self-motivated and project-oriented, whether independently or with a team
• Good sense of urgency
• Strong technical skills are required
• Knowledge and experience in product development processes a plus
• Locate sources for engineering materials and services, obtain quotes and place orders for material and services
• Support communication activities regarding R&D initiatives
• Some program management duties as assigned
• Must be able to provide and utilize your own laptop

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