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Manufacturing Readiness Transfer Engineer

• 3.1 San Clemente, CA 92672 $38.00 - $49.50 an hour Apply with Indeed As a Manufacturing Readiness Transfer Engineer, you will take on a practical technical position focused on readying medical-device production workflows, machinery, tooling, documentation, and operational expertise for relocation to a new facility. By evaluating current production methods against established protocols, you will identify technical deficiencies, assess assets, and resolve readiness obstacles. Your work ensures the creation of a comprehensive, reliable transfer package, enabling the destination site to successfully implement, validate, and manage processes while effectively mitigating risks related to quality, safety, and service.

CORE DUTIES

Analyze production and support workflows at the originating site, covering areas such as medical tubing extrusion, secondary processing, inspection, packaging, logistics, maintenance, calibration, and quality documentation. You will record operational sequences, process variables, setup techniques, equipment specifications, troubleshooting protocols, and essential operator decision-making steps to ensure seamless knowledge sharing. Evaluate and structure technical equipment documentation, such as maintenance logs, installation qualification records, service manuals, calibration status, spare parts lists, and vendor information. Your efforts will help maintain high equipment reliability by identifying and resolving gaps in existing records. Produce or oversee the creation of essential technical assets, including tooling schematics, detailed drawings, specifications, and visual records. You will confirm that all tooling aligns with existing documentation or establish new baselines where formal records are currently absent. Assess process documentation by observing skilled personnel to ensure alignment between written procedures and actual shop-floor practices. This will help improve process repeatability at the new site by clarifying setup parameters, visual standards, data collection methods, and inspection criteria. Examine the transfer scope regarding Device Master Records and manufacturing documentation, such as bills of materials, process specifications, work instructions, and validation records. You will help ensure regulatory compliance and operational readiness by reconciling any missing or outdated information within the Design History File.

Professional Requirements:

Hold a Bachelor's degree in a relevant engineering field such as Mechanical, Manufacturing, Chemical, Biomedical, or Plastics, or possess equivalent technical training combined with significant practical experience. Bring at least five years of experience in manufacturing, process engineering, or equipment validation within a regulated industry, with a strong preference for those with a background in medical-device production. Demonstrate the ability to translate complex shop-floor knowledge into clear, actionable instructions, thereby helping the team achieve consistent and reliable production outcomes. Utilize your hands-on expertise with manufacturing hardware, fixtures, gauges, and maintenance systems to support the successful qualification and functional testing of production equipment. Apply your understanding of medical-device quality standards, such as ISO 13485 and FDA regulations, to help the organization maintain strict compliance and robust risk management throughout the transfer process.