Process Engineer (California Licensed)

Job Summary

A company is looking for a Process Engineer (Med Device).

Key Responsibilities

• Attend meetings to support engineering teams and provide process engineering guidance
• Draft documentation including study plans, protocols, and reports for FDA 510(k) submission
• Generate product technical specifications and define manufacturing layout for optimal process performance

Required Qualifications, Training, and Education

• Experience in process engineering within the medical device industry
• Knowledge of FDA 510(k) submission processes
• Ability to perform qualifications and support testing of medical devices
• Understanding of manufacturing layouts and process optimization
• Relevant degree in engineering or related field