Medical Device Manufacturing Engineer - Design Transfer

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

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