(Regulated Industry Experience Required!)


  • Manage manufacturing of medical device products.

  • Manufacture/assembly of finished product, including printing and application of labels.

  • Assisting in the establishment of an appropriate system of “Key Performance Indicators” (KPIs) that measure the efficiency and effectiveness of company’s manufacturing operations. KPIs such as: throughput, production yield, reject/scrap rate, delivery performance, etc.

  • Completion of all documentation related to manufacturing and release of product.

  • Determines the organization structure and staffing requirements of manufacturing operations.

  • Ensures that performance expectations for all manufacturing personnel are clear and that all staff are properly trained and provisioned to perform with excellence.

  • Responsible for overall management, motivation, direction and development of production personnel.

  • Responsible continuous Improvement activities.

  • Create, draft, revise SOP’s and other critical documents as needed.

  • Initiate and complete Planned Deviations, CAPA’s, and Non-Conformance documentation as required.


  • B.S. Degree.

  • Minimum 5 years of medical device manufacturing experience.

  • Experience in an ISO certified and GMP environment preferred.

  • Experience with Food and Drug Administration’s Quality System Regulations (QSRs), ISO 13485 and GMP is highly desirable.


Register for updates

Receive the latest updates from Breathe Technologies