Manufacturing Engineer

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

• 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.
• 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.