Manufacturing Engineer Pleasanton - CA - California

Job Summary:

5+ years of Medical device Manufacturing experience

Support in Manufacturing process remediation and readiness activities for new product launch.

Support Design Transfer deliverables, including tracking and scheduling.

SupportInitiate Change Order for manufacturing documentation such as but not limited to, manufacturing procedures, shop floor paperwork, and inspection procedures.

Risk Management updates PFMEA.

Part creation in Windchill. BOM and configuration management.

Work with cross functional teams as required, especially with R&D, Quality, and Regulatory teams.

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Preferred

Knowledge of ISO andor FDA quality system regulations as it pertains to design transfer and process control.