Pay: $30.00 - $40.00 per hour, with flexible schedule
Lead small scale medical device labeling projects to support R&D initiatives, quality / compliance initiatives, and market expansion.
Participate in cross-functional team meetings to define label requirements.
Support company's production facilities with implementation of labeling changes.
Process design change control documentation in the electronic change management system, and process label change orders in the electronic document management system for updates to labeling and related specifications. Revise product specifications and Bill of Materials to implement label changes.
Support and lead label changes as required by the new European MDR Regulation, complete Change Control documentation and work with the manufacturing facilities to implement the new labels.
Detail-oriented, process-oriented thinker with experience on cross-functional teams.
Bachelor’s degree required; concentration in engineering or packaging technology preferred.
Medical device background and/or experience with electronic document management systems and/or label/material specifications preferred.
Proficiency with standard Microsoft desktop applications and Adobe Acrobat required. Bar code / UDI experience is helpful.
Knowledge of country-specific regulatory requirements not required.