Manufacturing Engineer

Creative Solutions Services, LLC; Morgantown (WV); On-site; USD 85,000 - 115,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a manufacturing professional to support remediation and readiness for new product launches. You will help with design transfer, change control, and PFMEA updates, while coordinating with R&D, Quality, and Regulatory teams to remain compliant with FDA regulations and internal procedures.

Responsibilities include creating parts in Windchill, managing BOMs and configurations, and ensuring timely tracking and scheduling for design transfer deliverables.

Qualifications

• Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control.
• Experience in medical device manufacturing.
• 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 orders for manufacturing documentation (procedures, shop floor paperwork, inspection procedures).
• Risk management updates – PFMEA.
• Part creation in Windchill; BOM and configuration management.
• Collaborate with R&D, Quality, and Regulatory teams; ensure compliance with FDA regulations and company procedures.

Skills

ISO/FDA quality systems

Medical device manufacturing

Job description

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