Manufacturing Engineer

Katalyst CRO; Morgantown (WV); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO in Morgantown, WV seeks a manufacturing professional to support remediation, design transfer, and change order activities for new medical device products. You will contribute to PFMEA updates and BOM/configuration management using Windchill, collaborating with R&D, Quality and Regulatory teams.

The role requires knowledge of ISO/FDA quality systems and at least 5 years in medical device manufacturing, ensuring compliance with FDA regulations and company procedures across the

Qualifications

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

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 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.

Skills

Regulatory compliance

Quality systems

Cross-functional collaboration

Tools

Windchill

Job description

• 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.

Roles & 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 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.

Requirements

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