Manufacturing Engineer

Creative Solutions Services, LLC; Pleasanton (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Manufacturing Quality Specialist to support remediation and readiness activities for new product launches in our California facility.

The role focuses on design transfer, change control, PFMEA risk updates, Windchill BOM management, and cross-functional collaboration with R&D, Quality, and Regulatory teams to ensure compliance with ISO and FDA quality systems.

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 FDA regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Skills

Quality systems knowledge

Regulatory compliance

Design transfer

Process control

Medical devices

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