R&D Project Support and Documentation Coordinator

This position is responsible for the execution of development and manufacturing related documents, such as BOM’s, routers, labels, ECO, engineering document review, etc; to assure completeness and to initiate/implement manufacturing of suture and suture based devices for OEM customers.
REQUIREMENTS
Principal responsibilities:
Creates and modifies manufacturing documentation such as BOM’s, routers, drawings and procedures.
Create labeling from Labelmax templates or customer specs which includes external and internal L/A’s.
Perform label review and release in Labelmax.
Prepare ECO documentation for manufacturing/R&D.
Supports and reviews newly created documentation and labeling to assure accurate information transfer to the manufacturing floor.
Transfer customer specifications to internal specs for product development and manufacturing purposes.
Revise drawings, procedures, forms, labeling to capture required changes-i.e. ISO, labeling, FDA, Corporate.
Advise engineering on changes needed to specs or labels.
Work with engineering in the design of fixtures, packaging and customer devises.
Create appropriate documentation for customer samples to ensure regulations are met.

Job Specifications
Associate and/or Bachelor’s degree in related field.
Minimum 5 plus years R&D/manufacturing document preparation/coordination experience.
Ability to work within a team as well as independently.Ability to manage multiple projects required.
Working knowledge in PRMS, QAD, SAP, OASIS, QMIS, Corel, Quark, Adobe Illustrator, Microsoft Word, and Access.
Ability to manage and prioritize workload.
Working knowledge of sutures and suture related devices is a plus.
The ability to travel to customer accounts, suppliers and alternate manufacturing locations as needed is required. (Estimated Travel is 5%).