Manufacturing Engineer

Zenith services; Pleasanton (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Zenith services seeks a manufacturing specialist with 4–5 years of medical device manufacturing experience to support design transfer, process remediation, and readiness for new product launches.

You will collaborate with R&D, Quality, and Regulatory teams, manage change orders for documentation, and maintain PFMEA updates and Windchill BOM/configuration management to ensure FDA regulatory compliance.

Qualifications

• 4–5 years of medical device manufacturing experience.
• Experience with design transfer and process control.
• Ability to initiate and track change orders for documentation.

Responsibilities

• Support manufacturing process remediation and readiness for new product launches.
• Support/Initiate Change Order for manufacturing documentation.
• Update PFMEA and risk management activities.
• Create parts in Windchill; manage BOM and configuration.
• Collaborate with R&D, Quality and Regulatory teams.
• Ensure compliance with FDA regulations and company procedures.

Skills

Cross-functional collaboration

Risk Management (PFMEA)

Regulatory awareness

Tools

Windchill

BOM/configuration management

Job description

• 4 to 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.
• 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.

Preferred

• Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control.

Previous medical device experience