Medical Device Manufacturing Engineer — Launch & Process Excellence

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

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.