Job Description

About the Company

Kelly Engineering is seeking an R&D Specialist - Quality Documentation Specialist for a long-term contract at one of our Global Medical Device clients located in Irvine, CA . Our Client is a global leader in the science of diagnosing and treating heart rhythm disorders. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide.

About the Role

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 R&D team to coordinate activities related to new product development and the lifecycle . 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. Coordinate essential R&D tasks that include contracts with HCPs, training team associates, travel for HCC professionals and other R&D visitors, budget tracking and accruals per finance needs.

Responsibilities

• Function as Project Coordinator for the Device History File of a project team
• Sourcing engineering material for new product development
• Management of the supply chain for new product material
• Control of inventory
• Design control for new product development build activities from onset to submission
• Coordinate essential R&D tasks that include contracts with HCPs, training team associates, travel for HCC professionals and other R&D visitors, budget tracking and accruals per finance needs
• Manufacturing line support and DHR audit
• Being a self-starter is important in this role
• Lead the execution, audit, and closure of work orders
• 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

Qualifications

• A Bachelor’s Degree in a relevant field and 4-6 years ’ related work experience
• Associates Degree with 6+ years’ experience
• Manufacturing line support and DHR audit experience
• Medical device experience

Required Skills

• 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.)
• Self-motivated and project-oriented, whether independently or with a team
• 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

Pay range and compensation package

As a Kelly employee, you will be eligible for Medical & Dental 50% paid, 401K and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation and sick/personal time. All KellyOCG employees receive annual performance reviews.

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States immediately and without employer sponsorship. Not accepting C2C, H1B Visa or OPT right now.

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