Manufacturing Engineer

I3 INFOTEK INC; Pleasanton (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

I3 INFOTEK INC in Pleasanton, CA seeks a candidate with 5+ years of Medical device manufacturing experience to support design transfer, remediation activities for new product launches, and change orders for manufacturing documentation. You will interact with R&D, Quality, and Regulatory teams to ensure compliance with FDA regulations and windchill-based configurations.

Knowledge of ISO and FDA quality systems is preferred to help drive process control and documentation accuracy during transfers

Qualifications

• 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.
• 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.

Skills

Medical device experience

Cross-functional collaboration

FDA regulations

Tools

Windchill

Job description

• 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.
• 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.