Medical Device Manufacturing Engineer – Design Transfer Expert

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

Job summary

Zenith Services Inc. is seeking a mid-level manufacturing professional with 4–5 years of medical device manufacturing experience to support remediation and readiness activities for new product launches.

You will assist with design transfer deliverables, track schedules, and initiate change orders affecting manufacturing documentation. Proficiency in Windchill for part creation and BOM/configuration management is required, as is collaboration with R&D, Quality, and Regulatory teams.

Qualifications

• 4–5 years of medical device manufacturing experience.
• Familiarity with ISO and FDA QMS for design transfer and process control is preferred.

Responsibilities

• Support in manufacturing process remediation and readiness activities for a new product launch.
• Support design transfer deliverables, including tracking and scheduling.
• Initiate/approve change orders for manufacturing documentation (procedures, shop floor paperwork, inspection procedures).
• Part creation in Windchill; BOM and configuration management.
• Collaborate with cross-functional teams, especially R&D, Quality, and Regulatory.
• Adhere to FDA regulations and company policies; maintain positive communications.

Skills

Medical device manufacturing

Windchill

Tools

Windchill

Job description

Zenith Services Inc. is seeking a mid-level manufacturing professional with 4–5 years of medical device manufacturing experience to support remediation and readiness activities for new product launches.

You will assist with design transfer deliverables, track schedules, and initiate change orders affecting manufacturing documentation. Proficiency in Windchill for part creation and BOM/configuration management is required, as is collaboration with R&D, Quality, and Regulatory teams.