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
Job Tags
Long term contract,