Medical Device R&D Project Specialist
1st Shift: 8AM-5PM
Employment Type: Full-Time
Compensation for this role is competitive, ranging from $38 to $45 per hour, depending on experience and qualifications.
Benefits: Comprehensive Benefit Package
Location: Irvine, CA
Functions: R&D Engineering (R&D)
Job Description:
Kelly Services, in partnership with a global leader in the science of diagnosing and treating heart rhythm disorders, is immediately hiring a qualified R&D Project Specialist. The company established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the company’s CARTO® 3 System in 2009 revolutionized 3D mapping technology by increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.
This position involves providing specialized support to project teams focused on the development of electrophysiology catheters and related accessories. The Project Specialist works closely with the team to coordinate activities related to new product development and its lifecycle management. This can include but not limited to sourcing engineering material for new product development, management of the supply chain for new product material, control of inventory, and design control for new product development build activities from onset to submission.
Key Responsibilities
- 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
- Support Compliance activities
- Function as Project Coordinator for the Device History File of a project team
- Locate sources for engineering materials and services, obtain quotes and place orders for material and services
- Lead/ supports the execution of work orders
- Manage the supply chain for new product development materials
- Manage inventory of new product development materials
- 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 communication activities regarding R&D initiatives
- Some program management duties as assigned
- Other duties as assigned
Experience and Education
- A Bachelor’s Degree in relevant field and 4-6 year’s related work experience
- Associates Degree with 6+ years’ experience
Preferred
- Medical device experience highly preferred
- In-depth knowledge of MS Office (i.e. Excel, Word, Outlook, and PowerPoint)
- Knowledge of PLM systems and required J&J systems (i.e. Totality, JDE, ARIBA, Windchill)
- Ability to work with internal engineers & external vendors, detailed oriental 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 manage (Product structure, Bills of Material, routings, etc.)
- Financial accounting experience a plus
- Knowledge and experience in product development processes a plus
Excellent opportunity for career minded seeking job security and advancement potential.
Qualified applicants are encouraged to apply.
Please submit an up-to-date resume for immediate consideration.
Thank You
Kelly Services
