Material Coordinator – R&D and Manufacturing (Medical Devices)
Position Summary
We are seeking a highly organized and proactive Material Coordinator to support our clients Research & Development and Manufacturing teams in the development of innovative medical devices. This role is essential for ensuring material readiness, enabling efficient kitting and assembly, and maintaining compliance with ISO 13485 and FDA regulations. The ideal candidate will have hands-on experience with ERP/MRP systems, strong cross-functional collaboration skills, and a proven track record supporting NPI builds from prototype through pilot.
Key Responsibilities
Material Readiness & Inventory Management
* Own materials readiness across 1K part and component codes
* Ensure materials are in the kit, on time, and to specification for each build.
* Drive kitting completeness and kit accuracy for work orders (WOs) and manufacturing orders (MOs).
* Manage shortages, cut-ins, and material changes driven by ECRs/ECOs.
* Support physical inventory counts and cycle count programs.
ERP/MRP Systems & Purchasing Support
* Help stand up ERP/MRP processes to enable efficient kitting and on-time assembly.
* Assist in creating and maintaining item masters, BOMs, routings, electronic inventory logs
* Load and maintain piece price, supplier, and lead-time data aligned with sourcing.
* Establish and maintain backflushing rules and lot/serial traceability workflows per ISO 13485.
* Place and track POs for components and sub-assemblies; own shortage management to closure.
* Partner with sourcing and suppliers to ensure clean cut-ins and timely deliveries.
Quality & Compliance
* Partner with Quality on incoming inspection, FAI, NCRs, quarantine, and disposition.
* Ensure compliance with ISO 13485 purchasing controls, DHR traceability, and sterile/shelf-life considerations.
* Support documentation and traceability for lot/serial numbers and material history.
* Author and update SOPs and work instructions for planning, purchasing, receiving, kitting, and inventory.
* Demonstrate mastery of BOMs, CO/ECR processes, inventory controls, and traceability.
NPI & Cross-Functional Collaboration
* Track record of supporting NPI builds (prototype → validation → pilot) and hitting material readiness dates.
* Collaborate closely with Engineering, Quality, Supply Chain, and Manufacturing teams to resolve material issues and support build schedules.
Qualifications
* Associate’s or Bachelor’s degree in Supply Chain, Business, Operations, or similar
* 2+ years of experience in material coordination, inventory control, or logistics in a regulated industry (medical devices preferred).
* Hands-on experience with ERP/MRP systems (NetSuite preferred).
* Strong understanding of GMP, ISO 13485, and FDA regulations.
* Excellent organizational, communication, and problem-solving skills.
* Proficiency in Microsoft Office Suite (Excel, Word, Outlook).