Project Engineer I - Injection Molding

Responsibilities

• Support the development, documentation, and validation of manufacturing processes (e.g., extrusion, molding, assembly) in compliance with ISO standards, country-specific and GMP regulations.
• Collaborate with cross-functional teams and customers to implement engineering initiatives, including standardization, continuous improvement activities, process improvements, and engineering change orders.
• Assist in the design and qualification of tooling, fixtures, and equipment, including generating and executing IQ/OQ/PQ protocols as required.
• Develop and maintain technical documentation such as BOMs, routers, manufacturing procedures, and work instructions.
• Provide day-to-day engineering support on manufacturing processes, including troubleshooting issues as they arise.
• Analyze test data, perform root cause investigations, and implement corrective actions to resolve quality issues and support CAPA/NCR activities.
• Improve productivity and reduce scrap/reject rates through automation, tool/process improvements, effective training of production personnel and process enhancements.
• Interfaces with customers and suppliers on project matters, mold and fixture design, validation, and product quality issues."

Requirements

• Bachelor's degree in Engineering, Chemistry, Biology, or related science/technical field.
• 0-3 years experience in a regulated industry
• Knowledge and exposure to injection molding, extrusion, and assembly, including the materials used such as plastic and silicone.
• Basic understanding of engineering terminology and manufacturing processes used in medical device production.
• Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.
• Understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971, Knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States)
• Basic understanding of process validation principles and reports, process window/repeatability studies, DOE's, IQ/OQ/PQ, and how to validate manufacturing processes to ensure consistent product quality and necessary safety protocols.
• Familiarity with product testing and inspection methods to ensure compliance with specifications and standards.
• Ability to maintain technical documentation, including work instructions, standard operating procedures (SOPs), and production records.
• ‎ ‎
• Freudenberg Medical LLC

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