Manufacturing Engineer

Responsibilities

• 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 manufacturing procedures, shop floor paperwork, and inspection procedures.
• Update Risk Management PFMEA.
• Part creation in Windchill, BOM, and configuration management.
• Work with cross-functional teams, especially with R&D, Quality, and Regulatory teams.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Requirements

• 5+ years of Medical device Manufacturing experience.

Preferred Qualifications

• Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control.
• Previous medical device experience.