Manufacturing Engineer

• 4 to 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.
• Support/Initiate 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 and/or FDA quality system regulations as it pertains to design transfer and process control.

Required Skills:

Medical device ManufacturingPFMEABOMWindchillMinitabFailure Mode & Effects AnalysisISO 13485FDAGMP